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

March 10, 2022 updated by: Dr. Pradip Gyanwali,MD, Nepal Health Research Council

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Nepal
    • Bagmati
      • Bharatpur, Bagmati, Nepal
        • Active, not recruiting
        • Chitwan Medical College
      • Kathmandu, Bagmati, Nepal
      • Lalitpur, Bagmati, Nepal
    • Lumbini
      • Butwāl, Lumbini, Nepal
        • Active, not recruiting
        • Lumbini Provincial Hospital
    • Province 2
      • Birgunj, Province 2, Nepal
        • Active, not recruiting
        • Narayani Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Artesunate
Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414
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.
Other Names:
  • Imatinib. Infliximab
EXPERIMENTAL: Imatinib
Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414
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.
Other Names:
  • Imatinib. Infliximab
EXPERIMENTAL: Infliximab
Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414
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.
Other Names:
  • Imatinib. Infliximab
NO_INTERVENTION: Local Standard of Care
No other Intervention Given except the local standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of duration of hospital stay,
Time Frame: 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
To assess the number of days in hospital due to COVID 19 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 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
Time Frame: The number of days calculated from date of randomization until the date of initiation of ventilation, assessed up to 28 days
To asses number of days ventilation requirement in the patient who are receiving study drug in addition to local standard of care
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)
Time Frame: Number of Serious Adverse Effect (SAE) calculated from the day of randomization upto 28 days
To assess the incidence of any Serious adverse reactions (SAE) in the patient who are receiving study drug in addition to local standard of care
Number of Serious Adverse Effect (SAE) calculated from the day of randomization upto 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nepal Health Research Council

Collaborators

World Health Organization

Investigators

  • Study Director: Dr Marie-Pierre Preziosi, WHO Solidarity Trial Plus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 6, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

December 10, 2021

First Submitted That Met QC Criteria

February 28, 2022

First Posted (ACTUAL)

March 10, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Solidarity Trial Plus In Nepal
  • ISRCTN18066414 (REGISTRY: ISRCTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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