NCT04570982: CPT-R-Nepal

Clinical Protocol for Convalescent Plasma and Remdesivir Therapy in Nepal

Status unknown Last updated 30 September 2020

What this trial tests

trial testing Convalescent Plasma in COVID-19 in 200 participants. Status unknown.

Timeline

30 July 2020

Primary endpoint
30 October 2020

30 December 2020

Quick facts

Lead sponsor	Dr. Pradip Gyanwali,MD
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	200
Start date	30 July 2020
Primary completion	30 October 2020
Estimated completion	30 December 2020
Sites	6 locations across Nepal

Drugs / interventions tested

• Convalescent Plasma — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Dr. Pradip Gyanwali,MD

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this compassionate use study is to provide access and evaluate the outcome of Remdesivir and COVID-19 convalescent plasma use in patients with COVID-19. This protocol provides a coordinated approach for distribution and guidance for safe and effective administration of Remdesivir and convalescent plasma with antibodies against SARS CoV-2 for treatment of patients with COVID-19 infection who are most likely to benefit from this investigational treatment and monitor them for the following specific objectives and outcomes:

SPECIFIC OBJECTIVES

1. Provide access to convalescent plasma for hospitalized patients with severe COVID-19 infection (compassionate use, expanded access program)
2. Monitor safety of the therapy with convalescent plasma containing antibodies against SAR CoV-2 and Remdesivir for hospitalized patients with severe COVID-19 infection
3. Evaluate outcomes in patients who received convalescent COVID-19 plasma therapy alone, Remdesivir alone, and both agents.

Study Design: This study will be a prospective, observational clinical study with an intention-to-treat, cross-over design. Comparison groups will be patients who received convalescent plasma vs. those who received Remdesivir. In addition, cross-over to convalescent plasma arm will be allowed for patients who continued to get worse even after receiving Remdesivir for more than 48 hours.

Publications & conference data

7 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. Remdesivir for treatment of COVID-19; an updated systematic review and meta-analysis.
   Rezagholizadeh A, Khiali S, Sarbakhsh P, Entezari-Maleki T. · · 2021 · cited 85× · PMID 33549577 · DOI 10.1016/j.ejphar.2021.173926
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. Experience of Treating COVID-19 With Remdesivir and Convalescent Plasma in a Resource-Limited Setting: A Prospective, Observational Study.
   Koirala J, Gyanwali P, Gerzoff RB, Bhattarai S, et al · · 2021 · cited 11× · PMID 34430672 · DOI 10.1093/ofid/ofab391
6. Convalescent plasma (hyperimmune immunoglobulin) for COVID-19 management: An update.
   Chavda VP, Bezbaruah R, Dolia S, Shah N, et al · · 2023 · cited 10× · PMID 36741339 · DOI 10.1016/j.procbio.2023.01.018
7. Treatment of COVID-19 in Hospitalized Patients with Remdesivir, Convalescent Plasma or Both in a Resource Limited Setting: A Prospective Study
   Koirala J, Dhimal M, Gerzoff RB, Bhattarai S, et al · · 2021 · DOI 10.2139/ssrn.3796911