SARS-CoV 2Phase 1/2NCT04366245
Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection
A Phase 1/2 study testing Hyperimmune plasma in people with SARS-CoV 2, run by Andalusian Network for Design and Translation of Advanced Therapies at 14 sites in Spain.
Trial summary
Phase I / II multicentre, randomized and controlled clinical trial to evaluate the efficacy of treatment with hyperimmune plasma obtained from convalescent antibodies of COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SARS-CoV 2
- What is being tested?
- Hyperimmune plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 14 sitesSpain
- Study dates
- 23 Apr 2020to 30 Dec 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent prior to performing procedures. the oral consent be accepted testified to prevent paper handling.
- Patient of both sexes, and ≥18 years.
- SARS-CoV-2 infection determined by PCR in a sample of naso-oropharyngeal exudate or other respiratory specimen or determination of specific positive IgM antibodies, in <72 hours before randomization.
- Patients requiring hospitalization for pneumonia COVID-19 without need until randomization of mechanical ventilation (invasive or non-invasive), and at least one of the following:
- O2 saturation ≤ 94% in ambient air, or PaO2 / FiO2 ≤ 300 mm Hg.
- Age> 65 years.
- Presence of: high blood pressure, chronic heart failure, chronic obstructive pulmonary disease, liver cirrhosis, or other chronic pulmonary and cardiovascular diseases, diabetes, or obesity
Who cannot join
- Requirement before randomization of mechanical ventilation (invasive or non-invasive).
- Any of the following analytical data before randomization: IL-6> 80 pg / mL, D-dimer> 10 times ULN, ferritin> 1000ng / mL.
- Participation in another clinical trial or experimental treatment for COVID-19.
- In the opinion of the clinical team, progression to death or mechanical ventilation is highly probable within 24 hours, regardless of treatment provision.
- Incompatibility or allergy to the administration of human plasma.
- Severe chronic kidney disease grade 4 or requiring dialysis (ie eGFR <30)
- Pregnant, lactating, or fertile women who are not using an effective method of contraception. It is considered a woman of childbearing age all women from 18 years and up to a year after the last menstrual period in the case of menopausal women
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Hospital U. Torrecárdenas
Almería, 04009
Hospital U. Puerta del Mar
Cadiz, 11009
Hospital U. Virgen de las Nieves
Granada, 18014
Hospital U. San Cecilio
Granada, 18016
Hospital Juan Ramón Jiménez
Huelva, 21005
Hospital U. Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407
Hospital Regional U. de Málaga
Málaga, 29010
Hospital U. Virgen de la Victoria
Málaga, 29010
Hospital Costa del Sol
Marbella, Málaga, 29603
Hospital U. Puerto Real
Puerto Real, Cádiz, 11510
Hospital Unversitario Virgen Macarena
Seville, 41009
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital U. Nuestra Señora de Valme
Seville, 41014
Hospital San Juan de Dios
Seville, 41930
About this study
Official title: Phase I / II Multicentre, Randomized and Controlled Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection
Phase I / II multicentre, randomized and controlled clinical trial to evaluate the efficacy of treatment with hyperimmune plasma obtained from convalescent antibodies of COVID-19 infection.
- Conditions
- SARS-CoV 2
- Being tested
- Hyperimmune plasma, Standard of care for SARS-CoV-2 infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperimmune plasmaBiological
PLASMA OF CONVALESCENT COVID-19
Standard of care for SARS-CoV-2 infectionDrug
Standard of care for SARS-CoV-2 infection
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Biological: Hyperimmune plasma |
| Comparator | Active comparator | Not described Receives: Drug: Standard of care for SARS-CoV-2 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE).
Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE).
Measured: 30 days after enrollment
Efficacy: Death from any cause
Measured: Day +21 after randomization
Efficacy: Need for mechanical ventilation
Measured: Day +21 after randomization
Efficacy: Any of the following analytical data after 72h of randomization.
IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL.
Measured: Day +21 after randomization
Efficacy: SOFA scale ≥ 3 after 72 hours of randomization or an increase of 2 points or more from the basal level
Measured: Day +21 after randomization
Secondary outcomes (10)
Efficacy. Mortality on days 14 and 28.
Measured: Days 14 and 28.
Efficacy: Proportion of patients who required mechanical ventilation
Measured: Until day 28
Efficacy: Proportion of patients who develop analytical alterations.
IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL until the cure test.
Measured: Day +21 after randomization.
Efficacy: Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test.
Measured: Day +21 after randomization
Efficacy: PCR negative for SARS-CoV-2
Measured: On days 7 and 21
Efficacy: Proportion of patients requiring treatment.
Proportion of patients requiring treatment with Tocilizumab Sarilumab, Anakimra or other IL-6 or IL-1 antagonists, or corticosteroids at doses of methylprednisolone greater than 2 mg / Kg / day (or equivalent) and / or any investigational medication.
Measured: Until day 21.
Efficacy: Duration of hospitalization (days)
Measured: Until day 21.
Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample
Measured: At baseline and on day 21
Virology and immunological variables: Total antibody quantification
Measured: At baseline and on days 3, 7 and 21
Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19.
Measured: Before infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start23 Apr 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV 2Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalusian Network for Design and Translation of Advanced Therapies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366245
- Sponsor's protocol ID
- PC/COVID-19
- Status last verified
- Apr 2022
- First submitted
- 22 Apr 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I / II Multicentre, Randomized and Controlled Clinical Trial to Evaluate the Efficacy of Treatment With Hyperimmune Plasma Obtained From Convalescent Antibodies of COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04366245
- Acronym / sponsor ID
- PC/COVID-19
- Conditions
- SARS-CoV 2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Andalusian Network for Design and Translation of Advanced TherapiesUniversity, hospital or other
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I / II multicentre, randomized and controlled clinical trial to evaluate the efficacy of treatment with hyperimmune plasma obtained from convalescent antibodies of COVID-19 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Biological: Hyperimmune plasma |
| Comparator | Active comparator | Drug: Standard of care for SARS-CoV-2 infection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent prior to performing procedures. the oral consent be accepted testified to prevent paper handling.
- Patient of both sexes, and ≥18 years.
- SARS-CoV-2 infection determined by PCR in a sample of naso-oropharyngeal exudate or other respiratory specimen or determination of specific positive IgM antibodies, in <72 hours before randomization.
- Patients requiring hospitalization for pneumonia COVID-19 without need until randomization of mechanical ventilation (invasive or non-invasive), and at least one of the following:
Key exclusion criteria (7 listed)
- Requirement before randomization of mechanical ventilation (invasive or non-invasive).
- Any of the following analytical data before randomization: IL-6> 80 pg / mL, D-dimer> 10 times ULN, ferritin> 1000ng / mL.
- Participation in another clinical trial or experimental treatment for COVID-19.
- In the opinion of the clinical team, progression to death or mechanical ventilation is highly probable within 24 hours, regardless of treatment provision.
- Incompatibility or allergy to the administration of human plasma.
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 |
|---|---|---|
| Hyperimmune plasmaPLASMA OF CONVALESCENT COVID-19 | Biological | Experimental |
| Standard of care for SARS-CoV-2 infectionStandard of care for SARS-CoV-2 infection | Drug | Comparator |
Primary outcome
Safety: Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE).
Time frame: 30 days after enrollment
Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE).
Efficacy: Death from any cause
Time frame: Day +21 after randomization
Efficacy: Need for mechanical ventilation
Time frame: Day +21 after randomization
Efficacy: Any of the following analytical data after 72h of randomization.
Time frame: Day +21 after randomization
IL-6> 80 pg / mL, D-dimer> 10 times, ferritin> 1000 ng / mL.
Efficacy: SOFA scale ≥ 3 after 72 hours of randomization or an increase of 2 points or more from the basal level
Time frame: Day +21 after randomization
10 secondary outcomes
Efficacy. Mortality on days 14 and 28.
Time frame: Days 14 and 28.
Efficacy: Proportion of patients who required mechanical ventilation
Time frame: Until day 28
Efficacy: Proportion of patients who develop analytical alterations.
Time frame: Day +21 after randomization.
Efficacy: Cure / clinical improvement (disappearance or improvement of signs and symptoms of COVID-19) in the cure test.
Time frame: Day +21 after randomization
Efficacy: PCR negative for SARS-CoV-2
Time frame: On days 7 and 21
Efficacy: Proportion of patients requiring treatment.
Time frame: Until day 21.
Efficacy: Duration of hospitalization (days)
Time frame: Until day 21.
Virology and immunological variables: Qualitative PCR for SARS-CoV-2 in naso-oropharyngeal exudate sample
Time frame: At baseline and on day 21
Virology and immunological variables: Total antibody quantification
Time frame: At baseline and on days 3, 7 and 21
Virology and immunological variables: Quantification of total antibodies in PC donors recovered from COVID-19.
Time frame: Before infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
Related trials for SARS-CoV 2
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruiting
Effect of MxA Guidance on Antiviral Treatment in Respiratory Viral Infections
Respiratory Viral Infections, Influenza
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia
SARS CoV 2 Infection, Influenza A Virus Infection
RecruitingObservational study
Determinants of SARS (Severe Acute Respiratory Syndrome)-COV2 (COVID-19) Persistence After Convalescence
COVID-19, Corona Virus Infection
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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hyperimmune plasma in people with SARS-CoV 2, run by Andalusian Network for Design and Translation of Advanced Therapies at 14 sites in Spain.
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 7 inclusion and 7 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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety: Incidence of Adverse Events and Serious Adverse Events grade 3 and 4, related to the product under investigation or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE). (time frame: 30 days after enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2022.