COVID-19Phase 2NCT04343755
Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection
A Phase 2 study testing Convalescent Plasma in people with COVID-19, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection. Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Convalescent Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2020to 26 Apr 2023
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Donor Eligibility Criteria:
- Age 18-60
- A history of a positive nasopharyngeal swab for COVID-19 or a history of positive titer test.
- At least 14 days from resolution of COVID-19-associated symptoms including fevers
- One negative nasopharyngeal swabs for COVID-19 RNA
- Covid-19 neutralizing antibody >1:64
- Adequate venous access for apheresis
- Meets donor eligibility criteria in accordance to Hackensack University Medical Center (HUMC) Collection Facility at the John Theurer Cancer Center (JTCC) if collecting at the JTCC, and all regulatory agencies as describes in SOP 800 01 (Appendix A)
- Required testing of the donor and product must be performed in accordance to FDA regulations (21 CFR 610.40), and the donation must be found suitable (21 CFR 630.30)
Recipient Eligibility Criteria:
Recipients age >18 years old, are assigned to one of two clinical tracks, track 2 or 3, based on COVID-19 disease severity. Onset of first symptoms < 9 days.
Track 2:
- Hospitalized, moderate symptoms requiring medical care for COVID-19 infection
- Symptoms may include fever, dyspnea, dehydration among others
- Hypoxemia may be present but is not a requirement
Track 3:
- Requiring mechanical ventilation for the care of COVID-19 infection
- Requiring non-invasive positive pressure ventilation (NIPPV), such as continuous airway pressure (CPAP),bi-level positive airway pressure (BiPAP) or high flow nasal canula (HFNC).
Recipient exclusion criteria:
- History of severe transfusion reaction to plasma products
- Infusion of immune globulin within the previous 30 days
- AST or ALT > 10 x upper limit of normal
- Requirement for vasopressors
- COVID-19-associated acute kidney injury requiring dialysis
- DNR status
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: Phase IIa Study Exploring the Safety and Efficacy of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Hospitalized Subjects With COVID-19 Infection
- This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.
- Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
- Interim analysis will be permitted as described in the statistical section 8.
- The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.
Read the detailed description
Overall study design
- This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.
- Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
- Interim analysis will be permitted as described in the statistical section 8.
- The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.
Number of subjects
- Up to 36 patients in track 2, and 19 patients in track 3 as described in the statistical section 8.
Overall study duration
- The study begins when the first subject (this will likely be a donor) signs the informed consent. The study will end once the last enrolled subject completes the study (likely a recipient).
- The expected duration of the study is approximately 12 months.
- Conditions
- COVID-19
- Being tested
- Convalescent Plasma
- Keywords
- Coronavirus, Covid19, SARS-CoV-2
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent PlasmaBiological
Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
| Study group | Role | What they receive |
|---|---|---|
| Convalescent Plasma | Experimental | Fresh or frozen plasma will be infused one time to patients Receives: Biological: Convalescent Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Hospitalized for COVID-19 But Not Intubated
Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients
Measured: 7 Days
Primary Objective for Patients With COVID-19 Already Intubated
Mortality rate at 30 days from starting treatment for patients with COVID-19
Measured: 30 Days
Secondary outcomes (13)
Duration of Hospitalization
The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death. Patients who are not discharged, are alive and still in the hospital on the date of closing follow-up, or lost follow-up on the date of closing follow-up will be considered censored on that date.
Measured: 60 Days
Duration of Mechanical Ventilation
The duration of mechanical ventilation is defined as the time in days from the first day of using mechanical ventilation to the last day of using mechanical ventilation. All evaluable patients will be included and no censoring for this analysis.
Measured: 60 Days
Time to Symptoms Resolution
The time to symptom resolution is defined as the time in days from new therapy initiation to the first documented symptom resolution as assessed by local site. Patients whose symptom are not resolved, who are dead, or lost follow-up on the designed follow-up date will be censored on that date.
Measured: 60 Days
Overall Survival
Overall survival rate at 60 days from starting treatment for patients with COVID-19
Measured: 60 Days
Rate of Virologic Clearance by Nasopharyngeal Swab at Day 10
Measured: 10 Days
Rate of Virologic Clearance by Nasopharyngeal Swab at Day 30
Measured: 30 Days
Impact of Donor Titers Level on Efficacy
Measured: 60 Days
Impact of Donor Titers Level on Safety
Measured: 60 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion)
Measured: 0 Days (pre-infusion)
Recipient Anti-SARS-CoV2 Titer Assessment on Days 3
Measured: 3 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Day 10
Measured: 10 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Day 30
Measured: 30 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Day 60
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start9 Apr 2020
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Why it stopped: Lack of eligible patients due to change in standard therapy
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 (19)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele L Donato, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343755
- Sponsor's protocol ID
- Pro2020-0375
- Status last verified
- Sep 2023
- First submitted
- 8 Apr 2020
- Last updated
- 18 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
PubMed 32192578Casadevall A, Scharff MD. Serum therapy revisited: animal models of infection and development of passive antibody therapy. Antimicrob Agents Chemother. 1994 Aug;38(8):1695-702. doi: 10.1128/AAC.38.8.1695. No abstract available.
PubMed 7985997Casadevall A, Scharff MD. Return to the past: the case for antibody-based therapies in infectious diseases. Clin Infect Dis. 1995 Jul;21(1):150-61. doi: 10.1093/clinids/21.1.150.
PubMed 7578724Casadevall A, Pirofski LA. Antibody-mediated regulation of cellular immunity and the inflammatory response. Trends Immunol. 2003 Sep;24(9):474-8. doi: 10.1016/s1471-4906(03)00228-x. No abstract available.
PubMed 12967670Casadevall A, Dadachova E, Pirofski LA. Passive antibody therapy for infectious diseases. Nat Rev Microbiol. 2004 Sep;2(9):695-703. doi: 10.1038/nrmicro974.
PubMed 15372080Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.
PubMed 32167489Zhang JS, Chen JT, Liu YX, Zhang ZS, Gao H, Liu Y, Wang X, Ning Y, Liu YF, Gao Q, Xu JG, Qin C, Dong XP, Yin WD. A serological survey on neutralizing antibody titer of SARS convalescent sera. J Med Virol. 2005 Oct;77(2):147-50. doi: 10.1002/jmv.20431.
PubMed 16121363Sahr F, Ansumana R, Massaquoi TA, Idriss BR, Sesay FR, Lamin JM, Baker S, Nicol S, Conton B, Johnson W, Abiri OT, Kargbo O, Kamara P, Goba A, Russell JB, Gevao SM. Evaluation of convalescent whole blood for treating Ebola Virus Disease in Freetown, Sierra Leone. J Infect. 2017 Mar;74(3):302-309. doi: 10.1016/j.jinf.2016.11.009. Epub 2016 Nov 17.
PubMed 27867062Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.
PubMed 15616839Yeh KM, Chiueh TS, Siu LK, Lin JC, Chan PK, Peng MY, Wan HL, Chen JH, Hu BS, Perng CL, Lu JJ, Chang FY. Experience of using convalescent plasma for severe acute respiratory syndrome among healthcare workers in a Taiwan hospital. J Antimicrob Chemother. 2005 Nov;56(5):919-22. doi: 10.1093/jac/dki346. Epub 2005 Sep 23.
PubMed 16183666Ko JH, Seok H, Cho SY, Ha YE, Baek JY, Kim SH, Kim YJ, Park JK, Chung CR, Kang ES, Cho D, Muller MA, Drosten C, Kang CI, Chung DR, Song JH, Peck KR. Challenges of convalescent plasma infusion therapy in Middle East respiratory coronavirus infection: a single centre experience. Antivir Ther. 2018;23(7):617-622. doi: 10.3851/IMP3243. Epub 2018 Jun 20.
PubMed 29923831Arabi YM, Hajeer AH, Luke T, Raviprakash K, Balkhy H, Johani S, Al-Dawood A, Al-Qahtani S, Al-Omari A, Al-Hameed F, Hayden FG, Fowler R, Bouchama A, Shindo N, Al-Khairy K, Carson G, Taha Y, Sadat M, Alahmadi M. Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV Infection, Saudi Arabia. Emerg Infect Dis. 2016 Sep;22(9):1554-61. doi: 10.3201/eid2209.151164.
PubMed 27532807Gunn BM, Yu WH, Karim MM, Brannan JM, Herbert AS, Wec AZ, Halfmann PJ, Fusco ML, Schendel SL, Gangavarapu K, Krause T, Qiu X, He S, Das J, Suscovich TJ, Lai J, Chandran K, Zeitlin L, Crowe JE Jr, Lauffenburger D, Kawaoka Y, Kobinger GP, Andersen KG, Dye JM, Saphire EO, Alter G. A Role for Fc Function in Therapeutic Monoclonal Antibody-Mediated Protection against Ebola Virus. Cell Host Microbe. 2018 Aug 8;24(2):221-233.e5. doi: 10.1016/j.chom.2018.07.009.
PubMed 30092199Wan Y, Shang J, Sun S, Tai W, Chen J, Geng Q, He L, Chen Y, Wu J, Shi Z, Zhou Y, Du L, Li F. Molecular Mechanism for Antibody-Dependent Enhancement of Coronavirus Entry. J Virol. 2020 Feb 14;94(5):e02015-19. doi: 10.1128/JVI.02015-19. Print 2020 Feb 14.
PubMed 31826992Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.
PubMed 25030060
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Study Exploring the Safety and Efficacy of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Hospitalized Subjects With COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04343755
- Acronym / sponsor ID
- Pro2020-0375
- Conditions
- COVID-19
- Keywords
- Coronavirus, Covid19, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of eligible patients due to change in standard therapy
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Posted 18 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.
- Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
- Interim analysis will be permitted as described in the statistical section 8.
- The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.
Detailed description
Overall study design
- This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.
- Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
- Interim analysis will be permitted as described in the statistical section 8.
- The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.
Number of subjects
- Up to 36 patients in track 2, and 19 patients in track 3 as described in the statistical section 8.
Overall study duration
- The study begins when the first subject (this will likely be a donor) signs the informed consent. The study will end once the last enrolled subject completes the study (likely a recipient).
- The expected duration of the study is approximately 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Convalescent Plasma | Experimental | Biological: Convalescent PlasmaFresh or frozen plasma will be infused one time to patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Convalescent PlasmaFresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection | Biological | Convalescent Plasma |
Primary outcome
Number of Participants Hospitalized for COVID-19 But Not Intubated
Time frame: 7 Days
Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients
Primary Objective for Patients With COVID-19 Already Intubated
Time frame: 30 Days
Mortality rate at 30 days from starting treatment for patients with COVID-19
13 secondary outcomes
Duration of Hospitalization
Time frame: 60 Days
Duration of Mechanical Ventilation
Time frame: 60 Days
Time to Symptoms Resolution
Time frame: 60 Days
Overall Survival
Time frame: 60 Days
Rate of Virologic Clearance by Nasopharyngeal Swab at Day 10
Time frame: 10 Days
Rate of Virologic Clearance by Nasopharyngeal Swab at Day 30
Time frame: 30 Days
Impact of Donor Titers Level on Efficacy
Time frame: 60 Days
Impact of Donor Titers Level on Safety
Time frame: 60 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion)
Time frame: 0 Days (pre-infusion)
Recipient Anti-SARS-CoV2 Titer Assessment on Days 3
Time frame: 3 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Day 10
Time frame: 10 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Day 30
Time frame: 30 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Day 60
Time frame: 60 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32192578Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.
- Background: PubMed 7985997Casadevall A, Scharff MD. Serum therapy revisited: animal models of infection and development of passive antibody therapy. Antimicrob Agents Chemother. 1994 Aug;38(8):1695-702. doi: 10.1128/AAC.38.8.1695. No abstract available.
- Background: PubMed 7578724Casadevall A, Scharff MD. Return to the past: the case for antibody-based therapies in infectious diseases. Clin Infect Dis. 1995 Jul;21(1):150-61. doi: 10.1093/clinids/21.1.150.
- Background: PubMed 12967670Casadevall A, Pirofski LA. Antibody-mediated regulation of cellular immunity and the inflammatory response. Trends Immunol. 2003 Sep;24(9):474-8. doi: 10.1016/s1471-4906(03)00228-x. No abstract available.
- Background: PubMed 15372080Casadevall A, Dadachova E, Pirofski LA. Passive antibody therapy for infectious diseases. Nat Rev Microbiol. 2004 Sep;2(9):695-703. doi: 10.1038/nrmicro974.
- Background: PubMed 32167489Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.
- Background: PubMed 16121363Zhang JS, Chen JT, Liu YX, Zhang ZS, Gao H, Liu Y, Wang X, Ning Y, Liu YF, Gao Q, Xu JG, Qin C, Dong XP, Yin WD. A serological survey on neutralizing antibody titer of SARS convalescent sera. J Med Virol. 2005 Oct;77(2):147-50. doi: 10.1002/jmv.20431.
- Background: PubMed 27867062Sahr F, Ansumana R, Massaquoi TA, Idriss BR, Sesay FR, Lamin JM, Baker S, Nicol S, Conton B, Johnson W, Abiri OT, Kargbo O, Kamara P, Goba A, Russell JB, Gevao SM. Evaluation of convalescent whole blood for treating Ebola Virus Disease in Freetown, Sierra Leone. J Infect. 2017 Mar;74(3):302-309. doi: 10.1016/j.jinf.2016.11.009. Epub 2016 Nov 17.
- Background: PubMed 15616839Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.
- Background: PubMed 16183666Yeh KM, Chiueh TS, Siu LK, Lin JC, Chan PK, Peng MY, Wan HL, Chen JH, Hu BS, Perng CL, Lu JJ, Chang FY. Experience of using convalescent plasma for severe acute respiratory syndrome among healthcare workers in a Taiwan hospital. J Antimicrob Chemother. 2005 Nov;56(5):919-22. doi: 10.1093/jac/dki346. Epub 2005 Sep 23.
- Background: PubMed 29923831Ko JH, Seok H, Cho SY, Ha YE, Baek JY, Kim SH, Kim YJ, Park JK, Chung CR, Kang ES, Cho D, Muller MA, Drosten C, Kang CI, Chung DR, Song JH, Peck KR. Challenges of convalescent plasma infusion therapy in Middle East respiratory coronavirus infection: a single centre experience. Antivir Ther. 2018;23(7):617-622. doi: 10.3851/IMP3243. Epub 2018 Jun 20.
- Background: PubMed 27532807Arabi YM, Hajeer AH, Luke T, Raviprakash K, Balkhy H, Johani S, Al-Dawood A, Al-Qahtani S, Al-Omari A, Al-Hameed F, Hayden FG, Fowler R, Bouchama A, Shindo N, Al-Khairy K, Carson G, Taha Y, Sadat M, Alahmadi M. Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV Infection, Saudi Arabia. Emerg Infect Dis. 2016 Sep;22(9):1554-61. doi: 10.3201/eid2209.151164.
- Individual participant dataSharing planned: No
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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.
Michele L Donato, MD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Convalescent Plasma in people with COVID-19, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 18 Sep 2023). 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 Hospitalized for COVID-19 But Not Intubated (time frame: 7 Days). The study lists 2 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 NCT04343755, which also lists 19 linked publications.
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 18 Sep 2023.