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

NCT ID: NCT05273242

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-06
• Study Completion Date: 2022-12-31

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.

Detailed 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

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Artesunate

Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414

Group Type: EXPERIMENTAL

Artesunate Injection

Intervention Type: DRUG

• 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.

Imatinib

Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414

Group Type: EXPERIMENTAL

Artesunate Injection

Intervention Type: DRUG

• 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.

Infliximab

Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414

Group Type: EXPERIMENTAL

Artesunate Injection

Intervention Type: DRUG

• 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.

Local Standard of Care

No other Intervention Given except the local standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Imatinib. Infliximab

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

World Health Organization

OTHER

Sponsor Role: collaborator

Nepal Health Research Council

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Pradip Gyanwali,MD

Executive Chief (Member Secretary)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Marie-Pierre Preziosi

Role: STUDY_DIRECTOR

WHO Solidarity Trial Plus

Locations

Chitwan Medical College

Bharatpur, Bagmati, Nepal

Site Status: ACTIVE_NOT_RECRUITING

Civil Service Hospital

Kathmandu, Bagmati, Nepal

Site Status: RECRUITING

Patan Academy of Health Sciences

Lalitpur, Bagmati, Nepal

Site Status: NOT_YET_RECRUITING

Lumbini Provincial Hospital

Butwāl, Lumbini, Nepal

Site Status: ACTIVE_NOT_RECRUITING

Narayani Hospital

Birgunj, Madhesh, Nepal

Site Status: ACTIVE_NOT_RECRUITING

Countries

Nepal

Central Contacts

Dr Pradip Gyanwali, MD

Role: CONTACT

prgyawali654@gmail.com

4254220

Prof. Dr. Janak Koirala, MD/MPH

Role: CONTACT

clinicaltrialnepal@gmail.com

9818762117

Facility Contacts

Dr. Bidesh Bista, MD

Role: primary

bideshbista@hotmail.com

9841762180

Dr. Pradip Tiwari, MD

Role: backup

pradptiwari@gmail.com

9851184760

Prof. Dr. Yubaraj Sharma, MD

Role: primary

yubarajsharma@pahs.edu.np

Other Identifiers

ISRCTN18066414

Identifier Type: REGISTRY

Identifier Source: secondary_id

Solidarity Trial Plus In Nepal

Identifier Type: -

Identifier Source: org_study_id