Overview

Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications

Status:
Active, not recruiting
Trial end date:
2021-08-09
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Max Healthcare Insititute Limited
Criteria
Inclusion Criteria:

- 1. Patients admitted with RT-PCR confirmed COVID-19 illness. 2. Age > 18 years 3.
Written informed consent 4. Has any of the two

1. PaO2/ FiO2 <300

2. Respiratory Rate > 24/min and SaO2 < 93% on room air

Or In case of Severe or immediately life-threatening COVID-19, for example:

a. 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

Exclusion Criteria:

- 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