Add-on Study on WHO Solidarity Trial Plus for COVID-19 in Nepal
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
2 other identifiers
interventional
400
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 covid19
Started Dec 2021
Typical duration for phase_4 covid19
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 6, 2021
CompletedFirst Submitted
Initial submission to the registry
December 10, 2021
CompletedFirst Posted
Study publicly available on registry
March 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 25, 2022
March 1, 2022
12 months
December 10, 2021
March 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of the Hospital Mortality
To assess the incidence of hospital mortality in the patient who are receiving study drug in addition to local standard of care
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
Secondary Outcomes (3)
Assessment of duration of hospital stay,
The duration in the number of days calculated from the first date hospitalization due to COVID 19 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 28 days
Initiation of ventilation
The number of days calculated from date of randomization until the date of initiation of ventilation, assessed up to 28 days
Assessment of Serious adverse reactions (SAE)
Number of Serious Adverse Effect (SAE) calculated from the day of randomization upto 28 days
Study Arms (4)
Artesunate
EXPERIMENTALPlease refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414
Imatinib
EXPERIMENTALPlease refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414
Infliximab
EXPERIMENTALPlease refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414
Local Standard of Care
NO INTERVENTIONNo other Intervention Given except the local standard of care
Interventions
* 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.
Eligibility Criteria
You may qualify if:
- Recently hospitalized (or already in hospital) with laboratory-confirmed COVID
- In the view of their doctors, no contra-indication to any potentially relevant study drug.
- Voluntary Participation
You may not qualify if:
- In the view of the randomising doctor, ANY of the AVAILABLE study drugs are contra-indicated (eg, because of patient characteristics, chronic liver or heart disease, or some concurrent medication).
- If expected to be transferred within 72 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nepal Health Research Councillead
- World Health Organizationcollaborator
Study Sites (5)
Chitwan Medical College
Bharatpur, Bagmati, Nepal
Civil Service Hospital
Kathmandu, Bagmati, Nepal
Patan Academy of Health Sciences
Lalitpur, Bagmati, Nepal
Lumbini Provincial Hospital
Butwāl, Lumbini, Nepal
Narayani Hospital
Birgunj, Madhesh, Nepal
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr Marie-Pierre Preziosi
WHO Solidarity Trial Plus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Chief (Member Secretary)
Study Record Dates
First Submitted
December 10, 2021
First Posted
March 10, 2022
Study Start
December 6, 2021
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
March 25, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share