NCT04375098

Efficacy and Safety of Early COVID-19 Convalescent Plasma in Patients Admitted for COVID-19 Infection

Completed Phase 2 Last updated 16 September 2020

What this trial tests

Phase 2 trial testing COVID-19 convalescent plasma in Severe Acute Respiratory Syndrome Coronavirus 2 in 58 participants. Completed in 17 August 2020.

Timeline

4 May 2020

Primary endpoint
17 August 2020

17 August 2020

Quick facts

Lead sponsor	Pontificia Universidad Catolica de Chile
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	4 May 2020
Primary completion	17 August 2020
Estimated completion	17 August 2020
Sites	1 location across Chile

Drugs / interventions tested

• COVID-19 convalescent plasma — full drug profile →

Conditions studied

• Severe Acute Respiratory Syndrome Coronavirus 2 — all drugs for Severe Acute Respiratory Syndrome Coronavirus 2 →

Sponsor

Pontificia Universidad Catolica de Chile — full company profile →

Who can join

18 and older, any sex, with Severe Acute Respiratory Syndrome Coronavirus 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Currently there is no standard treatment for SARS-CoV-2 infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including SARS-CoV-1 , MERS-CoV and Hantavirus infection. This study is an open-label randomized trial in which patients with high risk of COVID19-associated respiratory failure will be randomized to early treatment with convalescent plasma (≤ 7 days from symptoms start) or at early signs of respiratory failure or prolonged hospitalization. COVID-19 convalescent plasma will be collected from individuals according to the institutional protocol.

Publications & conference data

8 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, Chai KL, Valk SJ, Doree C, et al · · 2020 · cited 148× · PMID 32648959 · DOI 10.1002/14651858.cd013600.pub2
2. 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
3. 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
4. Early versus deferred anti-SARS-CoV-2 convalescent plasma in patients admitted for COVID-19: A randomized phase II clinical trial.
   Balcells ME, Rojas L, Le Corre N, Martínez-Valdebenito C, et al · · 2021 · cited 75× · PMID 33657114 · DOI 10.1371/journal.pmed.1003415
5. Treatment of COVID-19 with convalescent plasma: lessons from past coronavirus outbreaks.
   Wooding DJ, Bach H. · · 2020 · cited 55× · PMID 32791241 · DOI 10.1016/j.cmi.2020.08.005
6. Immunotherapeutic approaches to curtail COVID-19.
   Owji H, Negahdaripour M, Hajighahramani N. · · 2020 · cited 45× · PMID 32877828 · DOI 10.1016/j.intimp.2020.106924
7. Insights into neutralizing antibody responses in individuals exposed to SARS-CoV-2 in Chile.
   Beltrán-Pavez C, Riquelme-Barrios S, Oyarzún-Arrau A, Gaete-Argel A, et al · · 2021 · cited 29× · PMID 33579701 · DOI 10.1126/sciadv.abe6855
8. Cancer, immune suppression and Coronavirus Disease-19 (COVID-19): Need to manage drug safety (French Society for Oncology Pharmacy [SFPO] guidelines).
   Slimano F, Baudouin A, Zerbit J, Toulemonde-Deldicque A, et al · · 2020 · cited 29× · PMID 32623296 · DOI 10.1016/j.ctrv.2020.102063