COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43005

DrJAYANTHI RANGARAJAN

dranbuselvimk@gmail.com

2020-05-25

Not recruiting

RCT

Randomized

Parallel

Not reported

multi-center

Treatment

A. INCLUSION CRITERIA FOR DONOR: <br/ > Convalescent plasma: Eligibility of Donor <br/ >Potential donors will include the following: <br/ >1. Prior diagnosis of COVID-19 documented by a laboratory test , treated and completely recovered from Covid infection. <br/ >2. Complete resolution of symptoms and at least one negative lab test for Covid-19 at least 28 days prior to donation (as per NBTC guidelines after Covid -19 pandemic for donor selection). <br/ >3. If plasma is collected prior to 28 days after full recovery from illness, then confirmation of the resolution of the infection should be obtained through demonstration of two nasopharyngeal swab tests for SARS-CoV-2 performed at an interval of at least 24 hours on nasopharyngeal swabs. <br/ > These individuals will be contacted telephonically and explained the details of the study and their extent of participation. If requested, they will be provided transport for the same. <br/ >Donor eligibility criteria: <br/ >The following eligibility criteria will be applied towards potential donors: <br/ >1. Only males and nulliparous female donors of weight > 55 kgs will be included. <br/ >2. 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. <br/ >3. 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. <br/ >4. In addition to the afore mentioned 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). <br/ >a) Blood group and antibody screening â?? Antibody screen positive donors will be deferred. <br/ >b) Donors with Hb >12.5g/dl, platelet count >1,50,000 per microliter of blood and TLC within normal limits will be accepted. <br/ >c) Screening for HIV, HBV and HCV by serology or NAT. Donor negative by both the tests will be included. <br/ >d) Screening for syphilis and malaria by serology. Negative donors will be included <br/ >e) Total serum protein. Donors with total serum protein > 6gm/dl will be accepted (as per Drugs and Cosmetics (Second Amendment) Rules, 2020) <br/ >f) Presence of IgG and IgM antibodies to covid-19 by quantification test as per manufacturerâ??s instruction. Donors negative for these will be deferred. <br/ >g) 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 CLIA. 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. <br/ >h) Molecular test for covid-19 either from nasopharyngeal swab specimens may be done depending on availability of tests. Donorâ??s positive will be deferred. <br/ > <br/ >B. INCLUSION CRITERIA FOR RECIPIENT OF CCP: <br/ >1. Age should be above 20 years for both genders. <br/ >2. Covid positive patients who are under treatment in the covid acute care facility, amongst whom are willing to give consent to p

EXCLUSION CRITERIA FOR DONOR: <br/ >Covid-19 infected patients who are under treatment with the criteria: <br/ >1. Consecutive 2 swabs positive for covid-19 <br/ >2. One molecular test for covid-19 positive â?? RT-PCR. <br/ >3. Clinically symptoms suggestive of covid-19. <br/ >4. Multiparous female and patient with co morbid conditions. <br/ > <br/ >EXCLUSION CRITERIA FOR RECIPIENTS: <br/ >1. Patients with any past history of transfusion reactions to blood products. <br/ >2. Receipt of Pooled Immunoglobulin in last 30 days <br/ >3. Critically ill patients: respiratory failure, Sepsis, Multiorgan failure, Shock (Requiring Vasopressor to maintain a MAP â?¥ 65mmHg or MAP below 65 mmHg) <br/ >4. Participating in any other clinical trial <br/ >5. Pregnant and lactating women. <br/ >6. Patients infected with Covid-19 not under criteria for severe covid condition. <br/ >7. Patients with any chronic history of coronary artery disease, coronary bypass surgery, acute pulmonary edema, Pulmonary embolism, Congestive heart failure, Malignant hypertension, Polycythemia Vera, Severe renal failure, Cirrhosis and with any implants.

2

Government of TamilNadu

20

50

India

Severe disease at enrollment

6: Severe disease at enrollment

90

To prevent progression to severe ARDS (P/F ratio 100) and all-cause Mortality at 1 month. <br/ >Timepoint: Improvement of clinical symptoms and investigations will be monitored daily for first 3 days; and on day 7; 14; 21; 28; once a month till 3 months.

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

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