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

NCT04374487 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-07-22

No results posted yet for this study

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.

Conditions

  • COVID 19

Interventions

DRUG

Convalescent Plasma

200 ml of ABO compatible plasma transfusion will be done to the subject randomized for the test arm therapy

OTHER

Standard Care Therapy

Subjects randomized to control group will be on standard care treatment according to Institutional Protocols.

Sponsors & Collaborators

  • Max Healthcare Insititute Limited

    lead OTHER

Principal Investigators

  • Sangeeta Pathak, MBBS,Diploma · Max Super Speciality Hospital, Saket (DDF)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-09
Primary Completion
2021-08-09
Completion
2021-08-09

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04374487 on ClinicalTrials.gov