NCT05273242

WHO Solidarity Trial Plus: An International Randomised Trial of Additional Treatments for COVID-19 in Hospitalised Patients Who Are All Receiving the Local Standard of Care in Nepal

Status unknown Phase 4 Last updated 10 March 2022

What this trial tests

Phase 4 trial testing Artesunate Injection in COVID-19 in 400 participants. Status unknown.

Timeline

6 December 2021

Primary endpoint
1 December 2022

1 December 2022

Quick facts

Lead sponsor	Nepal Health Research Council
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	400
Start date	6 December 2021
Primary completion	1 December 2022
Estimated completion	1 December 2022
Sites	5 locations across Nepal

Drugs / interventions tested

• Artesunate Injection

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Nepal Health Research Council

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Assessment of the Hospital Mortality
  Time frame: The duration in the number of days calculated from the first date of randomization of the patient till the final outcome in the hospital that the first documented progression or death due to COVID 19 up to 28 days whichever comes first
  To assess the incidence of hospital mortality in the patient who are receiving study drug in addition to local standard of care

Sponsor's own description

Proposal for Sub-Study to be conducted with the WHO Solidarity Plus Trial:

Apart from the data been collected as per the WHO Solidarity Trial Plus protocol, Nepal Health Research Council will conduct a sub-study to evaluate some components which are felt to be important in the local context but have not been included as part of the Solidarity Trial Plus. Rather that conducting a separate study, the following components can be evaluated by collecting additional data as a part of sub-study in the local context.

Publications & conference data

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

1. Cell deaths: Involvement in the pathogenesis and intervention therapy of COVID-19.
   Li X, Zhang Z, Wang Z, Gutiérrez-Castrellón P, et al · · 2022 · cited 58× · PMID 35697684 · DOI 10.1038/s41392-022-01043-6
2. Anti-SARS-CoV-2 activity of targeted kinase inhibitors: Repurposing clinically available drugs for COVID-19 therapy.
   Boytz R, Słabicki M, Ramaswamy S, Patten JJ, et al · · 2023 · cited 20× · PMID 36117402 · DOI 10.1002/jmv.28157
3. Excessive concentrations of kinase inhibitors in translational studies impede effective drug repurposing.
   Liu C, Leighow SM, McIlroy K, Lu M, et al · · 2023 · cited 1× · PMID 37852183 · DOI 10.1016/j.xcrm.2023.101227