Covid19Phase 2/3NCT04652102
A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older
A Phase 2/3 study testing CVnCoV in people with Covid19 and SARS-CoV-2, run by CureVac at 46 sites in 10 countries.
Trial summary
The primary objective of the randomized observer-blinded phase 2b/3 part of this trial is to demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS-CoV-2
- What is being tested?
- CVnCoV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39,680 participants
- Where
- 46 sitesin 10 countries
- Study dates
- 11 Dec 2020to 10 Jun 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants 18 years of age or older.
- Be willing and able to provide written informed consent prior to initiation of any trial procedures.
- Expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit.
- Females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or postmenopausal {defined as amenorrhea for ≥12 consecutive months prior to screening (Day 1) without an alternative medical cause}. A follicle-stimulating hormone (FSH) level may be measured at the discretion of the Investigator to confirm postmenopausal status.
- Females of childbearing potential: negative pregnancy test (human chorionic gonadotropin [hCG]) within 24 hours prior to each trial vaccination on Day 1 and Day 29.
- Females of childbearing potential must use highly effective methods of birth control from 2 weeks before the first administration of the trial vaccine until 3 months following the last administration. The following methods of birth control are considered highly effective when used consistently and correctly:
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- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal);
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable);
- Intrauterine devices;
- Intrauterine hormone-releasing systems;
- Bilateral tubal ligation;
- Vasectomized or infertile partner;
- Sexual abstinence {periodic abstinence (e.g., calendar, ovulation, symptothermal and post-ovulation methods) and withdrawal are not acceptable}.
Who cannot join
- History of virologically-confirmed COVID-19 illness.
- For females: pregnancy or lactation.
- Use of any investigational or non-registered product (vaccine or drug) within 28 days preceding the administration of trial vaccine or planned use during the trial.
- Receipt of any licensed vaccines within 28 days (for live vaccines) or 14 days (for inactivated or any other vaccines) prior to administration of the first trial vaccine.
- Prior administration of any investigational SARS-CoV-2 vaccine or another coronavirus (SARS-CoV, Middle East Respiratory Syndrome-CoV) vaccine or planned used during the trial.
- Any treatment with immunosuppressants or other immune-modifying drugs (including but not limited to anabolic steroids, corticosteroids, biologicals and methotrexate) for > 14 days total within 6 months preceding the administration of trial vaccine or planned use during the trial. For corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14 days or more. The use of inhaled, topical, or localized injections of corticosteroids (e.g., for joint pain/inflammation) is permitted.
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- Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination including known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); current diagnosis of or treatment for cancer including leukemia, lymphoma, Hodgkin disease, multiple myeloma or generalized malignancy; chronic renal failure or nephrotic syndrome; and receipt of an organ or bone marrow transplant.
- History of angioedema (hereditary or idiopathic) or history of any anaphylactic reaction.
- History of potential immune-mediated disease (pIMD).
- History of allergy to any component of CVnCoV.
- Administration of immunoglobulins or any blood products within 3 months prior to the administration of trial vaccine or planned receipt during the trial.
- Participants with a significant acute or chronic medical or psychiatric illness that, in the opinion of the Investigator, precludes trial participation (e.g., may increase the risk of trial participation, render the participant unable to meet the requirements of the trial, or may interfere with the participant's trial evaluations). These include severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological and psychiatric illnesses. However, those with controlled and stable cases can be included in the trial.
- Participants with impaired coagulation or any bleeding disorder in whom an IM injection or a blood draw is contraindicated.
- Foreseeable non-compliance with the trial procedure as judged by the Investigator.
- Roll-over Criteria for the Open-label Phase:
- Participants must have received at least 1 dose of CVnCoV during the randomized observer blinded phase.
- Participants must provide additional written informed consent to be eligible for the open label phase.
Trial locations and contacts
46 sites in 10 countries.
46 sites in 10 countries
Argentina9 sites
Instituto de Investigaciones Clinicas Quilmes
Buenos Aires, 1878
Hospital Interzonal General Agudos Prof. Dr. Ramon Carrillo
Buenos Aires, B1702FWM
Hospital Interzonal General de Agudos Vicente Lopez y Planes
Buenos Aires, B1748
Hospital Zonal General de Agudos Descentralizado Evita Pueblo de Berazategui
Buenos Aires, B1884LAD
Fundación Cenit Para La Investigación En Neurociencias
Buenos Aires, C1125 ABD
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, B7600FZN
Sanatorio Parque
Rosario, S2000
Corporación Médica Sanatorio
San Martin, B1650CSQ
Instituto De Investigaciones Clinica Zarate
Zárate, B2800DGH
Peru8 sites
Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales
Callao, 07006
Hospital de Chancay y Servicios básicos de Salud
Chancay, 15131
Clinica Medica San Martin
Ica, 11000
Instituto de Investigación Nutricional - Las Gardenias
Lima, 15024
Instituto de Investigación Nutricional - San Carlos
Lima, 15024
Instituto de Investigación Nutricional
Lima, 15024
Asociación Civil Impacta Salud y Educación
Lima, 15063
Centro de Investigación para ensayos Clínicos UPCH
Lima, 15102
Mexico6 sites
Panamerican Clinical research Mexico (Guadalajara)
Guadalajara, 44690
Panamerican Clinical Research Mexico S.A. DE C.V.
Juriquilla, 76226
Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran
Mexico City, 14080
CAIMED - México
Mexico City, 6760
Unidad de Medicina Especializada SMA
San Juan del Río, 76800
Centro Medico Zambrano Hellion TecSalud
San Pedro Garza García, 66278
Dominican Republic4 sites
Fundacion Dominicana de Perinatologia Pro Bebe
Santo Domingo, 10204
Instituto Dermatológico Dominicano y Cirugía de Piel Dr. Huberto Bogaert Díaz
Santo Domingo, 10305
Clínica Cruz Jiminian
Santo Domingo, 10501
Hospital General Regional Marcelino Vélez Santana
Santo Domingo, 11001
Panama4 sites
Centro De Vacunacion Internacional - CEVAXIN Chorreras
Panama City, 07064
Instituto de Investigaciones Científicas y Servicios de Alta Tecnología
Panama City, 07097
Centro De Vacunacion Internacional - CEVAXIN 24 Diciembre
Panama City, 07113
Centro de Vacunacion Internacional - CEVAXIN Avenida Mexico
Panama City, 10662
Belgium3 sites
Cohezio - Bruxelles
Brussels, 1000
Mensura
Brussels, 1030
Universitair Ziekenhuis Gent
Ghent, 9000
Colombia3 sites
Clínica de la Costa
Barranquilla, 80020
CAIMED - Bogota Clinical Research Center
Bogotá, 111621
Centro de Estudios en Infectología Pediátrica (CEIP)
Cali, 760042
Germany3 sites
Uniklinik Köln
Cologne, 50937
Ludwig-Maximilians-Universität München
München, 80802
Universitätsklinikum Tübingen - Institut für Tropenmedizin, Reisemedizin und Humanparasitologie
Tübingen, 72074
Netherlands3 sites
Noordwest Ziekenhuisgroep
Alkmaar, 1815JD
Amsterdam Universitair Medische Centra - Academisch Medisch Centrum
Amsterdam, 1105 AZ
The Julius Center - Utrecht Science Park - Stratenum
Utrecht, 3584 CX
Spain3 sites
OSI Eskerraldea-Enkarterri-Cruces/Hospital Universitario Cruces
Barakaldo, 48903
Hospital Universitario Donostia
Donostia / San Sebastian, 20014
Hospital Clínico San Carlos
Madrid, 28040
About this study
Official title: COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older
The primary objective of the randomized observer-blinded phase 2b/3 part of this trial is to demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve participants.
Read the detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
- Conditions
- Covid19, SARS-CoV-2
- Being tested
- CVnCoV, Placebo, Authorized/licensed vaccines for preventing COVID-19 (AV) as standard of care through their national vaccination program
- Keywords
- Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVnCoVBiological
Also called CV07050101
Intramuscular (IM) injection.
PlaceboBiological
Intramuscular (IM) injection.
Authorized/licensed vaccines for preventing COVID-19 (AV) as standard of care through their national vaccination programBiological
Intramuscular (IM) injection will be received as standard of care (SoC) outside the study.
| Study group | Role | What they receive |
|---|---|---|
| Randomized Observer-blinded Phase 2b: CVnCoV vaccine | Experimental | Participants will be vaccinated with CVnCoV 12 µg vaccine on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. Receives: Biological: CVnCoV |
| Randomized Observer-blinded Phase 2b: Placebo | Placebo comparator | Participants will be administered the matching placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. Receives: Biological: Placebo |
| Randomized Observer-blinded Phase 3: CVnCoV vaccine | Experimental | Participants will be vaccinated with CVnCoV 12 µg vaccine on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. Receives: Biological: CVnCoV |
| Randomized Observer-blinded Phase 3: Placebo | Placebo comparator | Participants will be administered the matching placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. Receives: Biological: Placebo |
| Open-label Phase | Experimental | After unblinding, the trial will shift from a randomized observer-blinded to an open-label design, and the following cohorts will be defined:
Cohort A: participants who received at least 1 dose of CVnCoV in the randomized observer-blinded phases and choose to receive an authorized/licensed vaccine for preventing COVID-19 (AV) as standard of care through their national vaccination program.
Cohort B: participants who received at least 1 dose of CVnCoV in the randomized observer-blinded phases and choose to remain in the trial without receiving any AV.
Participants on the placebo arm will be withdrawn. Receives: Biological: Authorized/licensed vaccines for preventing COVID-19 (AV) as standard of care through their national vaccination program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced a First Episode of Virologically-confirmed {Reverse Transcription Polymerase Chain Reaction (RT-PCR) Positive} Case of COVID-19 of Any Severity
A case of COVID-19 meeting the definition for primary efficacy analysis was defined as follows:
- Virologically-confirmed case of COVID-19 (of any severity) defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19.
- Symptom onset ≥ 15 days after second trial vaccination.
- First episode of virologically-confirmed COVID-19, i.e. the participant must not have had a history of virologically-confirmed COVID-19 illness at enrollment or have had developed a case of virologically-confirmed COVID-19 before 15 days after the second trial vaccination.
- Participant was SARS-CoV-2 naïve at baseline and Day 43 (defined as seronegative to N protein in the blood samples collected at baseline and Day 43).
- Primary efficacy cases were confirmed by an Adjudication Committee.
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Day 44 to Day 393
Number of Participants Who Experienced One or More Medically-attended Adverse Events (AE)
Medically-attended AEs were defined as AEs with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Clinic visits for COVID-19 testing resulting in negative test results were not considered as medically attended visits, if there is no confirmed diagnosis and no prescribed concomitant medication.
The Investigator assessed the relationship between trial vaccine and occurrence of each AE.
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Day 1 to Day 211
Number of Participants Who Experienced One or More Serious AE (SAE)
An SAE was defined as any untoward medical occurrence that, at any dose:
- Resulted in death.
- Was life-threatening.
- Required inpatient hospitalization or prolongation of existing hospitalization.
- Resulted in persistent disability/incapacity.
- Was a congenital anomaly/birth defect in the offspring of the participant.
- Was an important medical event.
The Investigator assessed the relationship between trial vaccine and occurrence of each SAE.
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Day 1 to Day 393
Intensity of SAEs as Per Investigator Assessment
An SAE was defined as any untoward medical occurrence that, at any dose:
- Resulted in death.
- Was life-threatening.
- Required inpatient hospitalization or prolongation of existing hospitalization.
- Resulted in persistent disability/incapacity.
- Was a congenital anomaly/birth defect in the offspring of the participant.
- Was an important medical event.
The Investigator made an assessment of intensity of each SAE reported during the trial. Each SAE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome.
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Day 1 to Day 393
Number of Participants Who Experienced One or More Adverse Event of Special Interest (AESI)
AESIs included:
- AEs with a suspected immune-medicated etiology.
- Other AEs relevant to SARS-CoV-2 vaccine development or the target disease.
The Investigator assessed the relationship between trial vaccine and occurrence of each AESI.
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Day 1 to Day 393
Number of Participants Who Experienced a Fatal SAE
A fatal SAE was defined as an SAE that resulted in death.
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Day 1 to Day 393
Phase 2b Participants Only: Number of Participants Who Experienced One or More Solicited AE
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary.
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36)
Phase 2b Participants Only: Intensity of Solicited AEs as Per Investigator Assessment
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary.
The Investigator made an assessment of intensity of each solicited AE reported during the trial. Each solicited AE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome.
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36)
Phase 2b Participants Only: Duration of Solicited AEs
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after Day 8 are included. In each case only the longest consecutive duration is displayed.
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36)
Phase 2b Participants Only: Number of Participants Who Experienced One or More Unsolicited AE
eDiaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Phase 2b Participants Only: Intensity of Unsolicited AEs as Per Investigator Assessment
eDiaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit.
The Investigator made an assessment of intensity of each unsolicited AE reported during the trial. Each unsolicited AE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome.
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
Number of Participants Who Experienced One or More AEs Leading to Vaccine Withdrawal or Trial Discontinuation
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Day 1 to Day 393
Secondary outcomes (10)
Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Moderate to Severe Case of COVID-19
Moderate cases defined by any 1 of the following:
- Shortness of breath/difficulty breathing
- Respiratory rate ≥20 to <30 breaths per min
- Abnormal SpO2 but still >93% on room air at sea level
- Clinical/radiographic evidence of lower respiratory tract disease
- Radiologic evidence of DVT
Severe cases defined by any 1 of the following:
- Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30breaths per minute, heart rate ≥125 per minute, SpO2 ≤93% on room air at sea level or PaO2/FIO2 <300 mm Hg)
- Respiratory failure (defined as needing high flow-oxygen, noninvasive ventilation, mechanical ventilation or ECMO)
- Evidence of shock (SBP <90mm Hg, DBP <60 mmHg or requiring vasopressors)
- Significant renal, hepatic, or neurologic dysfunction
- Admission to ICU
- Death
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Day 44 to Day 393
Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Severe Case of COVID-19
Severe COVID-19 cases were defined by any one of the following:
- Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air at sea level or PaO2/FIO2 < 300 mm Hg).
- Respiratory failure (defined as needing high flow-oxygen, noninvasive ventilation, mechanical ventilation or ECMO).
- Evidence of shock (SBP < 90mm Hg, DBP < 60 mmHg, or requiring vasopressors).
- Significant renal, hepatic, or neurologic dysfunction
- Admission to intensive care unit (ICU).
- Death.
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Day 44 to Day 393
Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity Due to Infection With "Wild Type" and "Alpha" SARS-CoV-2 Strains in SARS-CoV-2 Naïve Participants
The characterization of SARS-CoV-2 variants were implemented by viral whole genome sequencing of nasopharyngeal swab samples of participants followed by comparison with previously sequenced and typified genomes. The following phylogenetic clustering was applied:
- "Wild type" virus: WT/D614G, lineages A.1/B.1 without the variant of concerns (VOCs) (i.e., without B.1.1.7 [Alpha], B.1.351 [Beta], B.1.429 [Epsilon]).
- "UK" VOC: B.1.1.7 (Alpha).
A case of COVID-19 was defined as follows:
- Virologically-confirmed case of COVID-19 defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19.
- Symptom onset ≥ 15 days after second vaccination.
- First episode of virologically-confirmed COVID-19.
- Participant was SARS-CoV-2 naïve at baseline and Day 43.
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Day 44 to Day 393
Number of Participants Aged ≥ 61 Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity
A case of COVID-19 was defined as follows:
- Virologically-confirmed case of COVID-19 (of any severity) defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19.
- Symptom onset ≥ 15 days after second trial vaccination.
- First episode of virologically-confirmed COVID-19, i.e. the participant must not have had a history of virologically-confirmed COVID-19 illness at enrollment or have had developed a case of virologically-confirmed COVID-19 before 15 days after the second trial vaccination.
- Participant was SARS-CoV-2 naïve at baseline and Day 43 (defined as seronegative to N protein in the blood samples collected at baseline and Day 43).
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Day 44 to Day 393
Burden of Disease (BoD) Score #1 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19
Score #1 was defined as no disease (not infected or asymptomatic infection) = 0; mild or moderate disease = 1; severe disease = 2.
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Day 44 to Day 393
BoD Score #2 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19
Score #2 was defined as no disease (not infected or asymptomatic infection) = 0; disease without hospitalization = 1; disease with hospitalization = 2; death = 3.
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Measured: Day 44 to Day 393
SARS-CoV-2 Receptor Binding Domain (RBD) of Spike (S) Protein Antibody Levels on Days 1, 29, 43, 120 and 211
Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by enzyme- linked immunosorbent assay (ELISA) and expressed as geometric mean of titers (GMT) with 95% confidence interval (CI), by group. Individual values below the lower limit of quantification (LLOQ) were set to half of the LLOQ. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who tested positive for SARS-CoV-2 via PCR or N-protein antibodies had their data included up to the point of positive test result or symptom onset.
Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Measured: Days 1 (baseline), 29, 43, 120 and 211
Percentage of Participants Seroconverting to SARS-CoV-2 RBD of S Protein Antibodies on Days 29, 43, 120 and 211
Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by ELISA. Percentage with 95% CI of participants for whom a seroconversion was observed is presented by group. In participants who tested seronegative to the N protein for SARS-CoV-2 at baseline, seroconversion was defined as a fold increase above 1 in antibody titer against SARS-CoV-2 RBD of S protein. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who tested positive for SARS-CoV-2 via PCR or N-protein antibodies had their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Measured: Baseline and Days 29, 43, 120 and 211
SARS-CoV-2 Viral Neutralizing Antibody Levels on Days 1, 29, 43, 120 and 211
Titers of viral neutralizing antibodies were determined by an activity assay and expressed as GMT with 95% CI, by group. Individual values below the LLOQ were set to half of the LLOQ. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who have tested positive for SARS-CoV-2 via PCR or N-protein antibodies have their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Measured: Days 1 (baseline), 29, 43, 120 and 211
Percentage of Participants Seroconverting to SARS-CoV-2 Viral Neutralizing Antibodies on Days 29, 43, 120 and 211
Titers of viral neutralizing antibodies were determined by an activity assay. Percentage with 95% CI of participants for whom a seroconversion was observed is presented by group. In participants who tested seronegative to the N protein for SARS-CoV-2 at baseline, seroconversion was defined as a fold increase above 1 in antibody titer against SARS-CoV-2 neutralizing antibody titer. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who have tested positive for SARS-CoV-2 via PCR or N-protein antibodies have their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.
Measured: Baseline and Days 29, 43, 120 and 211
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start11 Dec 2020
- Primary completion10 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39,680 participants (actual)
Sponsor and investigators
- Lead sponsor
- CureVac
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652102
- Sponsor's protocol ID
- CV-NCOV-004
- Other IDs
- 2020-003998-22
- Status last verified
- Nov 2023
- First submitted
- 1 Dec 2020
- Last updated
- 29 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kremsner PG, Ahuad Guerrero RA, Arana-Arri E, Aroca Martinez GJ, Bonten M, Chandler R, Corral G, De Block EJL, Ecker L, Gabor JJ, Garcia Lopez CA, Gonzales L, Granados Gonzalez MA, Gorini N, Grobusch MP, Hrabar AD, Junker H, Kimura A, Lanata CF, Lehmann C, Leroux-Roels I, Mann P, Martinez-Resendez MF, Ochoa TJ, Poy CA, Reyes Fentanes MJ, Rivera Mejia LM, Ruiz Herrera VV, Saez-Llorens X, Schonborn-Kellenberger O, Schunk M, Sierra Garcia A, Vergara I, Verstraeten T, Vico M, Oostvogels L; HERALD Study Group. Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial. Lancet Infect Dis. 2022 Mar;22(3):329-340. doi: 10.1016/S1473-3099(21)00677-0. Epub 2021 Nov 23.
PubMed 34826381
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older
- ClinicalTrials.gov ID
- NCT04652102
- Acronym / sponsor ID
- CV-NCOV-004
- Conditions
- Covid19, SARS-CoV-2
- Keywords
- Vaccine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39,680 participants (actual)
- Lead sponsor
- CureVacIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Posted 29 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the randomized observer-blinded phase 2b/3 part of this trial is to demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve participants.
Detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Randomized Observer-blinded Phase 2b: CVnCoV vaccine | Experimental | Biological: CVnCoVParticipants will be vaccinated with CVnCoV 12 µg vaccine on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. |
| Randomized Observer-blinded Phase 2b: Placebo | Placebo comparator | Biological: PlaceboParticipants will be administered the matching placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. |
| Randomized Observer-blinded Phase 3: CVnCoV vaccine | Experimental | Biological: CVnCoVParticipants will be vaccinated with CVnCoV 12 µg vaccine on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. |
| Randomized Observer-blinded Phase 3: Placebo | Placebo comparator | Biological: PlaceboParticipants will be administered the matching placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. |
| Open-label Phase | Experimental | Biological: Authorized/licensed vaccines for preventing COVID-19 (AV) as standard of care through their national vaccination programAfter unblinding, the trial will shift from a randomized observer-blinded to an open-label design, and the following cohorts will be defined: Cohort A: participants who received at least 1 dose of CVnCoV in the randomized observer-blinded phases and choose to receive an authorized/licensed vaccine for preventing COVID-19 (AV) as standard of care through their national vaccination program. Cohort B: participants who received at least 1 dose of CVnCoV in the randomized observer-blinded phases and choose to remain in the trial without receiving any AV. Participants on the placebo arm will be withdrawn. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female participants 18 years of age or older.
- Be willing and able to provide written informed consent prior to initiation of any trial procedures.
- Expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit.
- Females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or postmenopausal {defined as amenorrhea for ≥12 consecutive months prior to screening (Day 1) without an alternative medical cause}. A follicle-stimulating hormone (FSH) level may be measured at the discretion of the Investigator to confirm postmenopausal status.
- Females of childbearing potential: negative pregnancy test (human chorionic gonadotropin [hCG]) within 24 hours prior to each trial vaccination on Day 1 and Day 29.
Key exclusion criteria (17 listed)
- History of virologically-confirmed COVID-19 illness.
- For females: pregnancy or lactation.
- Use of any investigational or non-registered product (vaccine or drug) within 28 days preceding the administration of trial vaccine or planned use during the trial.
- Receipt of any licensed vaccines within 28 days (for live vaccines) or 14 days (for inactivated or any other vaccines) prior to administration of the first trial vaccine.
- Prior administration of any investigational SARS-CoV-2 vaccine or another coronavirus (SARS-CoV, Middle East Respiratory Syndrome-CoV) vaccine or planned used during the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVnCoVAlso: CV07050101Intramuscular (IM) injection. | Biological | Randomized Observer-blinded Phase 2b: CVnCoV vaccine, Randomized Observer-blinded Phase 3: CVnCoV vaccine |
| PlaceboIntramuscular (IM) injection. | Biological | Randomized Observer-blinded Phase 2b: Placebo, Randomized Observer-blinded Phase 3: Placebo |
| Authorized/licensed vaccines for preventing COVID-19 (AV) as standard of care through their national vaccination programIntramuscular (IM) injection will be received as standard of care (SoC) outside the study. | Biological | Open-label Phase |
Primary outcome
Number of Participants Who Experienced a First Episode of Virologically-confirmed {Reverse Transcription Polymerase Chain Reaction (RT-PCR) Positive} Case of COVID-19 of Any Severity
Time frame: Day 44 to Day 393
A case of COVID-19 meeting the definition for primary efficacy analysis was defined as follows: * Virologically-confirmed case of COVID-19 (of any severity) defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19. * Symptom onset ≥ 15 days after second trial vaccination. * First episode of virologically-confirmed COVID-19, i.e. the participant must not have had a history of virologically-confirmed COVID-19 illness at enrollment or have had developed a case of virologically-confirmed COVID-19 before 15 days after the second trial vaccination. * Participant was SARS-CoV-2 naïve at baseline and Day 43 (defined as seronegative to N protein in the blood samples collected at baseline and Day 43). * Primary efficacy cases were confirmed by an Adjudication Committee. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Number of Participants Who Experienced One or More Medically-attended Adverse Events (AE)
Time frame: Day 1 to Day 211
Medically-attended AEs were defined as AEs with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Clinic visits for COVID-19 testing resulting in negative test results were not considered as medically attended visits, if there is no confirmed diagnosis and no prescribed concomitant medication. The Investigator assessed the relationship between trial vaccine and occurrence of each AE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Number of Participants Who Experienced One or More Serious AE (SAE)
Time frame: Day 1 to Day 393
An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event. The Investigator assessed the relationship between trial vaccine and occurrence of each SAE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Intensity of SAEs as Per Investigator Assessment
Time frame: Day 1 to Day 393
An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event. The Investigator made an assessment of intensity of each SAE reported during the trial. Each SAE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Number of Participants Who Experienced One or More Adverse Event of Special Interest (AESI)
Time frame: Day 1 to Day 393
AESIs included: * AEs with a suspected immune-medicated etiology. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. The Investigator assessed the relationship between trial vaccine and occurrence of each AESI. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Number of Participants Who Experienced a Fatal SAE
Time frame: Day 1 to Day 393
A fatal SAE was defined as an SAE that resulted in death. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Phase 2b Participants Only: Number of Participants Who Experienced One or More Solicited AE
Time frame: Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36)
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Phase 2b Participants Only: Intensity of Solicited AEs as Per Investigator Assessment
Time frame: Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36)
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. The Investigator made an assessment of intensity of each solicited AE reported during the trial. Each solicited AE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Phase 2b Participants Only: Duration of Solicited AEs
Time frame: Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36)
Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after Day 8 are included. In each case only the longest consecutive duration is displayed. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Phase 2b Participants Only: Number of Participants Who Experienced One or More Unsolicited AE
Time frame: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
eDiaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Phase 2b Participants Only: Intensity of Unsolicited AEs as Per Investigator Assessment
Time frame: Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57)
eDiaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator made an assessment of intensity of each unsolicited AE reported during the trial. Each unsolicited AE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
Number of Participants Who Experienced One or More AEs Leading to Vaccine Withdrawal or Trial Discontinuation
Time frame: Day 1 to Day 393
Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier.
10 secondary outcomes
Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Moderate to Severe Case of COVID-19
Time frame: Day 44 to Day 393
Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Severe Case of COVID-19
Time frame: Day 44 to Day 393
Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity Due to Infection With "Wild Type" and "Alpha" SARS-CoV-2 Strains in SARS-CoV-2 Naïve Participants
Time frame: Day 44 to Day 393
Number of Participants Aged ≥ 61 Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity
Time frame: Day 44 to Day 393
Burden of Disease (BoD) Score #1 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19
Time frame: Day 44 to Day 393
BoD Score #2 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19
Time frame: Day 44 to Day 393
SARS-CoV-2 Receptor Binding Domain (RBD) of Spike (S) Protein Antibody Levels on Days 1, 29, 43, 120 and 211
Time frame: Days 1 (baseline), 29, 43, 120 and 211
Percentage of Participants Seroconverting to SARS-CoV-2 RBD of S Protein Antibodies on Days 29, 43, 120 and 211
Time frame: Baseline and Days 29, 43, 120 and 211
SARS-CoV-2 Viral Neutralizing Antibody Levels on Days 1, 29, 43, 120 and 211
Time frame: Days 1 (baseline), 29, 43, 120 and 211
Percentage of Participants Seroconverting to SARS-CoV-2 Viral Neutralizing Antibodies on Days 29, 43, 120 and 211
Time frame: Baseline and Days 29, 43, 120 and 211
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34826381Kremsner PG, Ahuad Guerrero RA, Arana-Arri E, Aroca Martinez GJ, Bonten M, Chandler R, Corral G, De Block EJL, Ecker L, Gabor JJ, Garcia Lopez CA, Gonzales L, Granados Gonzalez MA, Gorini N, Grobusch MP, Hrabar AD, Junker H, Kimura A, Lanata CF, Lehmann C, Leroux-Roels I, Mann P, Martinez-Resendez MF, Ochoa TJ, Poy CA, Reyes Fentanes MJ, Rivera Mejia LM, Ruiz Herrera VV, Saez-Llorens X, Schonborn-Kellenberger O, Schunk M, Sierra Garcia A, Vergara I, Verstraeten T, Vico M, Oostvogels L; HERALD Study Group. Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial. Lancet Infect Dis. 2022 Mar;22(3):329-340. doi: 10.1016/S1473-3099(21)00677-0. Epub 2021 Nov 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
46 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CVnCoV in people with Covid19 and SARS-CoV-2, run by CureVac at 46 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Argentina, Peru, Mexico, Dominican Republic, Panama and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced a First Episode of Virologically-confirmed {Reverse Transcription Polymerase Chain Reaction (RT-PCR) Positive} Case of COVID-19 of Any Severity (time frame: Day 44 to Day 393). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04652102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.