COVID 19Phase 2NCT04374487
Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications
A Phase 2 study testing Convalescent Plasma in people with COVID 19, run by Max Healthcare Insititute Limited at 1 site in India.
Trial summary
The novel coronavirus disease (COVID-19), which began in Wuhan, China, in December 2019, has been declared to be a pandemic by the World Health Organization (WHO), Caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19 has resulted in 1,781,127 cases and 108,994 deaths globally (till 12th… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- 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
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 9 May 2020to 9 Aug 2021
- Phase
- Phase 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients admitted with RT-PCR confirmed COVID-19 illness. 2. Age > 18 years 3. Written informed consent 4. Has any of the two
- PaO2/ FiO2 <300
- Respiratory Rate > 24/min and SaO2 < 93% on room air
- Or In case of Severe or immediately life-threatening COVID-19, for example:
- Severe disease is defined as: i. dyspnea, ii. respiratory frequency ≥ 30/min, iii. blood oxygen saturation ≤ 93%, iv. partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or v. lung infiltrates > 50% within 24 to 48 hours b. Life-threatening disease is defined as: i. respiratory failure, ii. septic shock, and/or iii. multiple organ dysfunction or failure
Who cannot join
- 1. Pregnant women 2. Breastfeeding women 3. Known hypersensitivity to blood products 4. Receipt of Pooled Immunoglobulin in last 30 days 5. Participating in any other clinical trial 6. Clinical status precluding infusion of blood products
Trial locations and contacts
1 site in 1 country.
India1 site
Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)
New Delhi, National Capital Territory of Delhi, 110017
About this study
Official title: A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications
The novel coronavirus disease (COVID-19), which began in Wuhan, China, in December 2019, has been declared to be a pandemic by the World Health Organization (WHO), Caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19 has resulted in 1,781,127 cases and 108,994 deaths globally (till 12th April, 2020), affecting 199 countries and 2 international conveyances. US FDA has recently approved Convalescent Plasma from patients recovered from COVID 19 for the treatment of severe or life threatening COVID-19 infections. In a small case series, five critically ill COVID-19 patients with ARDS were treated with convalescent plasma containing neutralizing antibodies. Infusion of plasma was followed by improvement in clinical status in all five patients, with no deaths and the study reported that three patients were discharged, whilst two continued to be stable on mechanical ventilation. We designed this phase II, open label, randomized clinical trial with the primary objective to assess the safety and efficacy of the therapy in the second stage.
Read the detailed description
The study will be conducted over the period of one year on 100 Hospitalized, COVID-19 patients, fulfill the inclusion and exclusion criteria, and are admitted for care at COVID-19 management facilities in Max healthcare Hospital will be eligible for inclusion in the trial. This Phase II, open label, randomized controlled trial. Consecutive patients meeting the inclusion-exclusion criteria and providing informed consent will be randomly assigned to the test and the control group using random numbers generated by randomization.com. Patients in the test group will receive convalescent plasma and the control group will be on standard care.
COVID-19 convalescent plasma will be collected from recovered individuals if they are eligible to donate blood. For infusion of plasma existing SOP of the wards w.r.t transfusion of FFP should be followed with special care to monitor these patients during and post-24 hours of transfusion. An ABO compatible plasma bag of approx. 200ml will be issued maintaining all the blood bank records after thawing at 37 degree Celsius. The first plasma transfusion may be followed by one or two additional doses of 200 ml at 24 hours interval according to disease severity and tolerance of the infusions. Baseline data about the demography, clinical presentations, ongoing medical therapy, and clinical history of participants in both arms will be collected and compared. Response to convalescent plasma will be coded as a binary outcome - based on whether the composite primary end point is met or not. Adverse events associated with infusion of convalescent plasma will also be descriptively summarized and compared with the adverse events experienced by participants receiving standard of care.
Eligibility of Potential Donor
- Only males and nulliparous female donors of weight > 55 kgs will be included.
- Donor eligibility criteria for whole blood donation as per the departmental SOP will be followed in accordance to the Drugs \& Cosmetics Act 1940 and rules 1945 therein (as amended till March 2020). Donor will be screened, followed by brief physical examination.
- Donors not fit to donate blood based on the history and examination will be deferred and excluded from plasma donor pool for a time period specified by country regulation \& departmental SOPs.
- In addition to the aforementioned donor eligibility criteria, two EDTA samples (5 ml each) and one plain sample (5 ml) will be drawn for the following pre-donation tests as required for convalescent plasmapheresis (CPP).
- Blood group and antibody screening - Antibody screen positive donors will be deferred.
- Complete blood count including Hb, Hct, Platelet count, Total and differential leucocyte count. Donors with Hb>12.5g/dl, platelet count >1, 50,000 per microliter of blood and TLC within normal limits will be accepted.
- Screening for HIV, HBV and HCV by serology and NAT. Donor negative by both the tests will be included.
- Screening for syphilis and malaria by serology. Negative donors will be included
- Total serum protein. Donors with total serum protein > 6gm/dl will be accepted (as per Drugs and Cosmetics (Second Amendment) Rules, 2020)
- Titration of anti-COVID-19 (both IgG and IgM) antibodies and SARS- CoV-2 neutralizing antibodies may be done depending on availability of facilities at the time of testing. (Desired titers for IgG antibodies >1024 or neutralizing antibodies >40) doubling dilution of donor serum will be done and titration will be done using ELISA. If not done at the time of plasma collection the donor samples will be stored in aliquots at <-80° C to be tested at a later date.
- Molecular test for COVID-19 either from nasopharyngeal swab specimens or blood may be done depending on availability of tests. Donors positive will be deferred.
- Conditions
- COVID 19
- Being tested
- Convalescent Plasma, Standard Care Therapy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent PlasmaDrug
200 ml of ABO compatible plasma transfusion will be done to the subject randomized for the test arm therapy
Standard Care TherapyOther
Subjects randomized to control group will be on standard care treatment according to Institutional Protocols.
| Study group | Role | What they receive |
|---|---|---|
| Test Arm | Experimental | 50 subjects will be randomized in this arm. Patients in the test group will receive convalescent plasma. Receives: Drug: Convalescent Plasma |
| Control Arm | Other | 50 subjects will be randomized in this arm and will be treated according to the standard care. The Ministry of Health and Welfare has issued detailed guidelines for the management of sCOVID-19 based on varying grades of severity. For the management of ARDS or sepsis, the respective guidelines issued by ARDSNet and Surviving Sepsis campaign will be followed. Other institutional protocols for supportive management will be implemented. Receives: Other: Standard Care Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is a composite measure of the avoidance of - 1. Progression to severe ARDS (P/F ratio 100) and 2. All-cause Mortality at 28 days
Baseline data about the demography, clinical presentations, ongoing medical therapy, and clinical history of participants in both arms will be collected and compared. Response to convalescent plasma will be coded as a binary outcome - based on whether the composite primary end point is met or not. All the statistical tests will be done at 5% level of significance and SPSS21 will be used for calculations.
Measured: depends on the total treatment time of the subjects within one year period of the trial.
Secondary outcomes (9)
Time to symptom resolution-Fever,Shortness of Breath,Fatigue
Data from both arm will be collected and compared time to time
Measured: one year
Hospital length of stay
total time of stay at hospital for the treatment and cure will be calculated and compared of both the arms
Measured: one year
Change in SOFA pre and post transfusion
sepsis-related organ failure assessment (SOFA) score will be calculated for both the arms and compared for the analysis.
Measured: one year
Duration of respiratory support required a. Duration of Invasive Mechanical Ventilation b. Duration of Non-Invasive
Most COVID patients admitted to intensive care require some form of respiratory support. Whether or not the plasma therapy decreases the duration of respiratory support and its comparison with the standard care therapy will be calculated.
Measured: one year
Radiological improvement
Comparison between group response rates will be analyzed by radiological imaging and reported.
Measured: one year
Adverse events (AE) associated with transfusion
Adverse events associated with infusion of convalescent plasma will also be descriptively summarized and compared with the adverse events experienced by participants receiving standard of care.
Measured: one year
To measure the change in RNA levels (Ct values) of SARS-CoV-2 from RT-PCR [Time Frame: Days 0, 1, 3, and 7 after transfusion]
Ct values from day 0, 1, 3 \& 7 will be calculated by RT-PCR and compared to check the response of therapy on the viral load. All the statistical tests will be done at 5% level of significance and SPSS21 will be used for calculations.
Measured: one year
Levels of bio-markers pre and post transfusion
Bio-markers can play a role in understanding how existing drugs can be used to treat Covid-19. Hence, pre and post Plasma transfusion the level of bio-markers will be checked and compared.
Measured: one year
Need of Vasopressor use
For critically ill subjects in both the arms the need of vasopressor will be compared. All these comparisons are for qualitative data and will be assessed for statistical significance by Fisher exact test in view of the small sample size.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start9 May 2020
- Primary completion9 Aug 2021 (estimated)
- Study completion9 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Healthcare Insititute Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sangeeta Pathak, MBBS,Diploma, Principal investigator, Max Super Speciality Hospital, Saket (DDF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374487
- Sponsor's protocol ID
- MHC-COVID-19-CP
- Status last verified
- Jul 2020
- First submitted
- 29 Apr 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications
- ClinicalTrials.gov ID
- NCT04374487
- Acronym / sponsor ID
- MHC-COVID-19-CP
- Conditions
- COVID 19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Max Healthcare Insititute LimitedUniversity, hospital or other
- Study start
- 9 May 2020 (actual)
- Primary completion
- 9 Aug 2021 (estimated)
- Study completion
- 9 Aug 2021 (estimated)
- First posted
- 5 May 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.
The novel coronavirus disease (COVID-19), which began in Wuhan, China, in December 2019, has been declared to be a pandemic by the World Health Organization (WHO), Caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19 has resulted in 1,781,127 cases and 108,994 deaths globally (till 12th April, 2020), affecting 199 countries and 2 international conveyances. US FDA has recently approved Convalescent Plasma from patients recovered from COVID 19 for the treatment of severe or life threatening COVID-19 infections. In a small case series, five critically ill COVID-19 patients with ARDS were treated with convalescent plasma containing neutralizing antibodies. Infusion of plasma was followed by improvement in clinical status in all five patients, with no deaths and the study reported that three patients were discharged, whilst two continued to be stable on mechanical ventilation. We designed this phase II, open label, randomized clinical trial with the primary objective to assess the safety and efficacy of the therapy in the second stage.
Detailed description
The study will be conducted over the period of one year on 100 Hospitalized, COVID-19 patients, fulfill the inclusion and exclusion criteria, and are admitted for care at COVID-19 management facilities in Max healthcare Hospital will be eligible for inclusion in the trial. This Phase II, open label, randomized controlled trial. Consecutive patients meeting the inclusion-exclusion criteria and providing informed consent will be randomly assigned to the test and the control group using random numbers generated by randomization.com. Patients in the test group will receive convalescent plasma and the control group will be on standard care.
COVID-19 convalescent plasma will be collected from recovered individuals if they are eligible to donate blood. For infusion of plasma existing SOP of the wards w.r.t transfusion of FFP should be followed with special care to monitor these patients during and post-24 hours of transfusion. An ABO compatible plasma bag of approx. 200ml will be issued maintaining all the blood bank records after thawing at 37 degree Celsius. The first plasma transfusion may be followed by one or two additional doses of 200 ml at 24 hours interval according to disease severity and tolerance of the infusions. Baseline data about the demography, clinical presentations, ongoing medical therapy, and clinical history of participants in both arms will be collected and compared. Response to convalescent plasma will be coded as a binary outcome - based on whether the composite primary end point is met or not. Adverse events associated with infusion of convalescent plasma will also be descriptively summarized and compared with the adverse events experienced by participants receiving standard of care.
Eligibility of Potential Donor
- Only males and nulliparous female donors of weight > 55 kgs will be included.
- Donor eligibility criteria for whole blood donation as per the departmental SOP will be followed in accordance to the Drugs \& Cosmetics Act 1940 and rules 1945 therein (as amended till March 2020). Donor will be screened, followed by brief physical examination.
- Donors not fit to donate blood based on the history and examination will be deferred and excluded from plasma donor pool for a time period specified by country regulation \& departmental SOPs.
- In addition to the aforementioned donor eligibility criteria, two EDTA samples (5 ml each) and one plain sample (5 ml) will be drawn for the following pre-donation tests as required for convalescent plasmapheresis (CPP).
- Blood group and antibody screening - Antibody screen positive donors will be deferred.
- Complete blood count including Hb, Hct, Platelet count, Total and differential leucocyte count. Donors with Hb>12.5g/dl, platelet count >1, 50,000 per microliter of blood and TLC within normal limits will be accepted.
- Screening for HIV, HBV and HCV by serology and NAT. Donor negative by both the tests will be included.
- Screening for syphilis and malaria by serology. Negative donors will be included
- Total serum protein. Donors with total serum protein > 6gm/dl will be accepted (as per Drugs and Cosmetics (Second Amendment) Rules, 2020)
- Titration of anti-COVID-19 (both IgG and IgM) antibodies and SARS- CoV-2 neutralizing antibodies may be done depending on availability of facilities at the time of testing. (Desired titers for IgG antibodies >1024 or neutralizing antibodies >40) doubling dilution of donor serum will be done and titration will be done using ELISA. If not done at the time of plasma collection the donor samples will be stored in aliquots at <-80° C to be tested at a later date.
- Molecular test for COVID-19 either from nasopharyngeal swab specimens or blood may be done depending on availability of tests. Donors positive will be deferred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Drug: Convalescent Plasma50 subjects will be randomized in this arm. Patients in the test group will receive convalescent plasma. |
| Control Arm | Other | Other: Standard Care Therapy50 subjects will be randomized in this arm and will be treated according to the standard care. The Ministry of Health and Welfare has issued detailed guidelines for the management of sCOVID-19 based on varying grades of severity. For the management of ARDS or sepsis, the respective guidelines issued by ARDSNet and Surviving Sepsis campaign will be followed. Other institutional protocols for supportive management will be implemented. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Patients admitted with RT-PCR confirmed COVID-19 illness. 2. Age > 18 years 3. Written informed consent 4. Has any of the two
- Severe disease is defined as: i. dyspnea, ii. respiratory frequency ≥ 30/min, iii. blood oxygen saturation ≤ 93%, iv. partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or v. lung infiltrates > 50% within 24 to 48 hours b. Life-threatening disease is defined as: i. respiratory failure, ii. septic shock, and/or iii. multiple organ dysfunction or failure
Key exclusion criteria (1 listed)
- 1. Pregnant women 2. Breastfeeding women 3. Known hypersensitivity to blood products 4. Receipt of Pooled Immunoglobulin in last 30 days 5. Participating in any other clinical trial 6. Clinical status precluding infusion of blood products
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 Plasma200 ml of ABO compatible plasma transfusion will be done to the subject randomized for the test arm therapy | Drug | Test Arm |
| Standard Care TherapySubjects randomized to control group will be on standard care treatment according to Institutional Protocols. | Other | Control Arm |
Primary outcome
The primary outcome is a composite measure of the avoidance of - 1. Progression to severe ARDS (P/F ratio 100) and 2. All-cause Mortality at 28 days
Time frame: depends on the total treatment time of the subjects within one year period of the trial.
Baseline data about the demography, clinical presentations, ongoing medical therapy, and clinical history of participants in both arms will be collected and compared. Response to convalescent plasma will be coded as a binary outcome - based on whether the composite primary end point is met or not. All the statistical tests will be done at 5% level of significance and SPSS21 will be used for calculations.
9 secondary outcomes
Time to symptom resolution-Fever,Shortness of Breath,Fatigue
Time frame: one year
Hospital length of stay
Time frame: one year
Change in SOFA pre and post transfusion
Time frame: one year
Duration of respiratory support required a. Duration of Invasive Mechanical Ventilation b. Duration of Non-Invasive
Time frame: one year
Radiological improvement
Time frame: one year
Adverse events (AE) associated with transfusion
Time frame: one year
To measure the change in RNA levels (Ct values) of SARS-CoV-2 from RT-PCR [Time Frame: Days 0, 1, 3, and 7 after transfusion]
Time frame: one year
Levels of bio-markers pre and post transfusion
Time frame: one year
Need of Vasopressor use
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- 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.
Sangeeta Pathak, MBBS,Diploma principal investigator
Max Super Speciality Hospital, Saket (DDF)
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 Max Healthcare Insititute Limited at 1 site in India.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Jul 2020. 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 India. 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?
Results are not available in the source record.
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?
The primary outcome is a composite measure of the avoidance of - 1. Progression to severe ARDS (P/F ratio 100) and 2. All-cause Mortality at 28 days (time frame: depends on the total treatment time of the subjects within one year period of the trial.). 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 22 Jul 2020.