Convalescent Plasma Treatment in COVID-19

Summary

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) occurred initially in December 2019 in the city of Wuhan, Hubei province, China. Patients mainly presented with respiratory symptoms and this novel pathogen was identified.At present, the core management of COVID-19 includes infection prevention, case detection, monitoring, and supportive care. While specific new drugs and vaccines are being researched, certain drugs that are already present in medical arsenal are under trial too.

One investigational treatment being explored for COVID-19 is the use of convalescent plasma (CP) collected from recovered COVID-19 patients. Convalescent Plasma is a source of passive immune therapy- the administration of specific antibodies against a given agent for preventing or treating an infectious disease due to that agent. The main anticipated mechanism of action of Convalescent Plasma therapy in COVID19 is viral neutralization. Other possible mechanisms include antibody-dependent cellular cytotoxicity and phagocytosis. There are numerous examples in which convalescent plasma (CP) has been used successfully as post exposure prophylaxis and/or treatment of infectious diseases, including other outbreaks of coronaviruses e.g. SARS-1, MERS-CoV and very recently in 2014, the Ebola virus outbreak. In SARS-CoV-2, Shen et al published a case series of 5 critically ill patients with COVID-19 and acute respiratory distress syndrome showing improvement in clinical status after transfusion of CP.

Therefore, the objective of this study is to determine the safety and efficacy of transfusing convalescent plasma in patients admitted with COVID-19 at Aga Khan University Karachi, Pakistan. The investigators hypothesize that CP will decrease the length of hospital stay and overall mortality in patients with COVID-19.

In this study, convalescent plasma will be collected from the donors who have been recovered from SARS-CoV-2 infection and transfused it to the patients admitted with active severe /critical COVID-19 at the Aga Khan University Hospital Karachi.

STUDY DESIGN: Non-randomized open Label trial

INCLUSION CRITERIA IN TREATMENT ARM:

i. Inpatients at AKU with positive SARS-CoV-2 infection by rRT-PCR and who have provided written informed consent for inclusion in the trial;

ii. Age ≥ 18 years;

iii. Severe or immediately life-threatening COVID-19 defined by any of:

* Respiratory rate ≥ 30/min;
* Blood oxygen saturation ≤ 93% at room air;
* Partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio \< 300;
* Lung infiltrates \> 50% within 24 to 48 hours on radiology ( X-ray or CT scan);
* Need for mechanical ventilation.
* respiratory failure
* septic shock
* multiple organ dysfunction or failure

EXCLUSION CRITERIA:

i. Negative rRT-PCR from respiratory secretions or blood within 48 h prior to assessment of eligibility.

ii. History of allergic reaction to blood or plasma products (as judged by the investigator).

iii. Medical conditions in which receipt of 500 mL intravascular volume may be detrimental to the patient (e.g., actively decompensated congestive heart failure).

iv. Enrolment in any other clinical trial for an investigational therapy.

CONTROL GROUP:

COVID-19 patients recruited during the period before CP becomes available or for whom no compatible CP is available will be given Standard of Care and will be followed for study outcomes. Data from these SC patients will be used as comparator in the analysis of the study.

Conditions

• Covid19

Interventions

BIOLOGICAL

Convalescent Plasma (CP)

500 ml of Convalescent plasma in a single dose will be transfused over a period of 1- 2 hours.

OTHER

Drugs and supportive care

This will include drugs like steroids, tocilizumab, azithromycin and supportive care

Sponsors & Collaborators

• Aga Khan University

  lead OTHER

Principal Investigators

• Muhammad Hasan, MBBS, FCPS · Aga Khan University Hospital, Karachi

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-04-26

Primary Completion

2020-09-15

Completion

2020-10-10

Countries

• Pakistan

Study Locations