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Add-on Study on WHO Solidarity Trial Plus for COVID-19 in Nepal

NCT05273242 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2022-03-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Artesunate Injection

* Artesunate: 2.4 mg/kg/dose at 0 hours, 12 hours, and 24 hours and thereafter every 24 hours; IV injection; duration of treatment 7 days. This is the standard dose recommended for the treatment of severe malaria. * Infliximab: 5 mg/kg/dose (once only), single IV infusion over 2 hours. This is the standard dose that is given repeatedly for the treatment of psoriasis. * Imatinib: 400 mg/dose; orally once daily; duration of treatment 14 days. This is the standard maintenance dose which is at the lower end of that used for several years in the treatment of hematological malignancies.

Sponsors & Collaborators

Principal Investigators

  • Dr Marie-Pierre Preziosi · WHO Solidarity Trial Plus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-06
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Nepal

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05273242 on ClinicalTrials.gov