A clinical trial for validating therapeutic efficacy of convalescent plasma in severe COVID-19 disease
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2020/05/025209
- Lead Sponsor
- Council of Scientific and Industrial Research
- Brief Summary
The coronavirus disease (COVID-19) caused by the novel coronavirus SARS-CoV2 has spread globally, with confirmed infected cases crossing 4.5 million worldwide resulting in more than 300,000 fatalities. On 11th of March, 2020, the World Health Organization (WHO) has declared COVID-19 to be a pandemic and research laboratories all over the world are working towards developing a vaccine and other therapeutic interventions. Passive immunization using convalescent plasma is an age-old therapeutic strategy in infections for which no vaccine or drugs with roven efficacy are available. Our aim is to study convalescent plasma therapy in an open label randomised control trial, which involves administration of plasma from patients who have recovered from COVID-19 infection to patients with severe COVID-19 disease, with or without mild or moderate acute respiratory distress syndrome. Primary objectives of this trial will be, 1) to compare progression to severe Acute Respiratory Distress Syndrome between two groups, 2) to compare ‘all cause’ mortality, 3) to identify the immune correlates for response to plasma therapy. Secondary outcomes are, 1) to compare recovery from acute respiratory distress syndrome in both groups, 2) to compare time taken to negative viral RNA PCR, 3) to document any adverse reaction to plasma therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Patients admitted with RNA PCR proven COVID-19 with severe disease (fever or suspected respiratory infection, plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2< 90% at room air) with Mild ARDS (200 mmHg < PaO2/FiO2 ≤ 300 mmHg, with PEEP or CPAP ≥5 cm H2O, or non-ventilated) or Moderate ARDS (100 mmHg < PaO2/FiO2 ≤200 mmHg, with PEEP ≥5 cm H2O, or non-ventilated) within 5 to 10 days from initial presentation.
- Pregnant mothers 2.
- Patients with age less than 18 years 3.
- Admitted late after 10 days of initial presentation 4.
- Patients refusing consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3. To identify the immune correlates for response to plasma therapy. 1. Discharge | 2. Discharge/death | 3. Day 0, Day 3, Day 7 after admission 2. To compare ‘all cause’ mortality 1. Discharge | 2. Discharge/death | 3. Day 0, Day 3, Day 7 after admission
- Secondary Outcome Measures
Name Time Method 1. To compare recovery from ARDS in both groups 2. To compare time taken to negative viral RNA PCR
Trial Locations
- Locations (1)
ID and BG Hospital COVID Hospital
🇮🇳Kolkata, WEST BENGAL, India
ID and BG Hospital COVID Hospital🇮🇳Kolkata, WEST BENGAL, IndiaDr Biswanath Sharma SarkarPrincipal investigator9434649592rimbisss@yahoo.co.in