NCT04476888: COLLATE

Convalescent Plasma Treatment in COVID-19

Completed NA Last updated 20 January 2021

What this trial tests

NA trial testing Convalescent Plasma (CP) in Covid19 in 110 participants. Completed in 10 October 2020.

Timeline

26 April 2020

Primary endpoint
15 September 2020

10 October 2020

Quick facts

Lead sponsor	Aga Khan University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	110
Start date	26 April 2020
Primary completion	15 September 2020
Estimated completion	10 October 2020
Sites	1 location across Pakistan

Drugs / interventions tested

• Convalescent Plasma (CP) — full drug profile →
• Drugs and supportive care

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Aga Khan University

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
   Piechotta V, Iannizzi C, Chai KL, Valk SJ, et al · · 2021 · cited 106× · PMID 34013969 · DOI 10.1002/14651858.cd013600.pub4
2. The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
   Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1
3. Convalescent plasma for people with COVID-19: a living systematic review.
   Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 24× · PMID 36734509 · DOI 10.1002/14651858.cd013600.pub5
4. Convalescent plasma for people with COVID-19: a living systematic review.
   Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 21× · PMID 37162745 · DOI 10.1002/14651858.cd013600.pub6
5. Repurposing of drugs targeting the cytokine storm induced by SARS-CoV-2.
   Ng WH, Tang PCH, Mahalingam S, Liu X. · · 2023 · cited 7× · PMID 36394425 · DOI 10.1111/bph.15987