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

Nepal Health Research Council

Status and phase: Unknown; Phase 4

Conditions: COVID-19

Treatments: Drug: Artesunate Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05273242

Solidarity Trial Plus In Nepal

ISRCTN18066414 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

Patients enrolled in the WHO Solidarity Plus trial will also be consented for this sub-study for further data collection in the following four categories. No additional tests or investigations will be performed.

1. Socio-economic factors: Investigators have added the socio-demographic factors in our data collection tool to get insight into the socio-demographic distribution of the hospitalized patients enrolled in the study. These data will help to understand the disease distribution in the local context. These factors are listed in the table below.
2. Laboratory investigations: There is no provision to collect the information on investigations including laboratory tests and radiological findings in the current WHO Solidarity protocol. These data will help to analyze the systemic effects of the study drugs and help to verify AEs/SAEs/SUSARs reported by the investigators. Hence, Investigators have added the information related to the various investigations in our study. Investigators will not collect additional bio samples or conduct any additional laboratory or radiological investigations. However, if such information is available, Investigators will collect such data and record the information in our local study database.
3. Immunization status: Investigators currently do not have studies looking at impact of vaccines on hospitalization, severity and mortality in Nepal. Data related to the vaccination status is not included in the Solidarity protocol. After the availability of the vaccine, vaccination status may be a confounding factor to determine the mortality outcome. Hence, investigators plan to add vaccine status as one of the variables in the sub-study.
4. Follow up after discharge: Investigators plan to add follow up visit or phone calls after the discharge which is not included in the current WHO Solidarity protocol. The study team will conduct follow up visits or phone calls each week to assess the status of the patients until 28 days and each month for six months thereafter from the date of first randomization. The follow up visits will be done by telephone call either to the patient or the patient's relative. Study team will ask about the condition of the patient since the time of discharge and find out general health status (normal versus abnormal), re-hospitalization, and mortality

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 4 patient groups

Artesunate

Experimental group

Description:

Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414

Treatment:

Drug: Artesunate Injection

Imatinib

Experimental group

Description:

Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414

Treatment:

Drug: Artesunate Injection

Infliximab

Experimental group

Description:

Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414

Treatment:

Drug: Artesunate Injection

Local Standard of Care

No Intervention group

Description:

No other Intervention Given except the local standard of care