NCT04346446 is a Phase 2 clinical trial of Convalescent Plasma Transfusion in COVID, sponsored by Institute of Liver and Biliary Sciences, India.

Who is sponsoring NCT04346446?

NCT04346446 is sponsored by Institute of Liver and Biliary Sciences, India.

What drugs are being tested in NCT04346446?

Interventions in NCT04346446: Convalescent Plasma Transfusion, Supportive Care, Random Donor Plasma.

Is NCT04346446 still recruiting?

NCT04346446 is currently completed. Last updated 12 June 2020.

Last reviewed 2020-06-12 · How we verify

NCT04346446

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy of Convalescent Plasma Therapy in Severely Sick COVID-19 Patients

Completed Phase 2 Last updated 12 June 2020

What this trial tests

Phase 2 trial testing Convalescent Plasma Transfusion in COVID in 29 participants. Completed in 30 May 2020.

Timeline

20 April 2020

Primary endpoint
30 May 2020

30 May 2020

Quick facts

Lead sponsor	Institute of Liver and Biliary Sciences, India
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	20 April 2020
Primary completion	30 May 2020
Estimated completion	30 May 2020
Sites	2 locations across India

Drugs / interventions tested

Convalescent Plasma Transfusion — full drug profile →
Supportive Care — full drug profile →
Random Donor Plasma — full drug profile →

Conditions studied

COVID — all drugs for COVID →

Sponsor

Institute of Liver and Biliary Sciences, India

Who can join

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

Sponsor's own description

Currently, no effective treatments are available for the COVID-19 pandemic, which is related to more than 70,000 deaths all over the world. Scientists and Researchers are working on many aspects of treatment options for the development of vaccination and medication to combat this life-threatening problem. Convalescent plasma from recovered COVID-19 patients contains antibodies against COVID-19 which may be beneficial to severely sick COVID019 infected patients. We have planned a randomized controlled trial to assess the efficacy of this therapy in COVID-19 infected sick patients. We will collect up to 500 ml Convalescent Plasma from the COVID-19 infected recovered patient after 14 days of clinical and radiological recovery with two consecutive COVID-19 negative tests by PCR. We will further test the sample from the collected plasma for COVID-19 specific antibodies and their titer. This plasma will be frozen and sent to the treating center (MAMC). 200-600 ml of convalescent plasma will be transfused to patients who fit the eligibility criteria and are randomized to the convalescent plasma group. This will be done in severely sick patients. Data will be collected for the benefit and adverse events related to convalescent plasma transfusion.

Publications & conference data

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

Cytokine storm and leukocyte changes in mild versus severe SARS-CoV-2 infection: Review of 3939 COVID-19 patients in China and emerging pathogenesis and therapy concepts.
Wang J, Jiang M, Chen X, Montaner LJ. · · 2020 · cited 551× · PMID 32534467 · DOI 10.1002/jlb.3covr0520-272r
COVID-19: Characteristics and Therapeutics.
Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
Association of Convalescent Plasma Treatment With Clinical Outcomes in Patients With COVID-19: A Systematic Review and Meta-analysis.
Janiaud P, Axfors C, Schmitt AM, Gloy V, et al · · 2021 · cited 189× · PMID 33635310 · DOI 10.1001/jama.2021.2747
Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
Piechotta V, Chai KL, Valk SJ, Doree C, et al · · 2020 · cited 148× · PMID 32648959 · DOI 10.1002/14651858.cd013600.pub2
Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a rapid review.
Valk SJ, Piechotta V, Chai KL, Doree C, et al · · 2020 · cited 126× · PMID 32406927 · DOI 10.1002/14651858.cd013600
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
Convalescent Plasma Therapy for COVID-19: State of the Art.
Focosi D, Anderson AO, Tang JW, Tuccori M. · · 2020 · cited 88× · PMID 32792417 · DOI 10.1128/cmr.00072-20
COVID-19 Convalescent Plasma and Clinical Trials: Understanding Conflicting Outcomes.
Focosi D, Franchini M, Pirofski LA, Burnouf T, et al · · 2022 · cited 79× · PMID 35262370 · DOI 10.1128/cmr.00200-21

Verify or expand the search:

Other trials of Convalescent Plasma Transfusion

Trials testing the same drug.

NCT04460547 — Worldwide Trends on COVID-19 Research After the Declaration of COVID-19 Pandemic · unknown

Other recruiting trials for COVID

Currently open trials in the same condition.

NCT06744660 — Clinical Validation of the Aptitude Medical Systems Metrix COVID-19 Test · NA · recruiting
NCT04910269 — Outpatient Treatment With Anti-Coronavirus Immunoglobulin · Phase 3 · recruiting
NCT04447833 — Mesenchymal Stromal Cell Therapy For The Treatment Of Acute Respiratory Distress Syndrome · Phase 1 · active not recruiting
NCT04351347 — The Efficacy of Ivermectin in Larger Doses in COVID-19 Treatment · Phase 2, PHASE3 · recruiting
NCT04382846 — Novel Regimens in COVID-19 Treatment · Phase 3 · recruiting

Other Institute of Liver and Biliary Sciences, India trials

Trials by the same sponsor.

NCT07480005 — To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies · recruiting
NCT07480057 — Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry · recruiting
NCT07465471 — Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis. · NA · not yet recruiting
NCT07433881 — Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis · not yet recruiting
NCT07422948 — Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04346446 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Institute of Liver and Biliary Sciences, India
Last refreshed: 12 June 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04346446.

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