COVID-19Phase 4NCT05273242
Add-on Study on WHO Solidarity Trial Plus for COVID-19 in Nepal
A Phase 4 study testing Artesunate Injection in people with COVID-19, run by Nepal Health Research Council at 5 sites in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Artesunate Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 5 sitesNepal
- Study dates
- 6 Dec 2021to Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Nepal5 sites, 2 recruiting
- Active, not recruiting
Chitwan Medical College
Bharatpur, Bagmati
- Active, not recruiting
Narayani Hospital
Birgunj, Madhesh
- Active, not recruiting
Lumbini Provincial Hospital
Butwal, Lumbini
- Recruiting
Civil Service Hospital
Kathmandu, Bagmati
Dr. Bidesh Bista, MD, 9841762180, bideshbista@hotmail.com
Dr. Pradip Tiwari, MD, 9851184760, pradptiwari@gmail.com
- Not yet recruiting
Patan Academy of Health Sciences
Lalitpur, Bagmati
Prof. Dr. Yubaraj Sharma, MD, yubarajsharma@pahs.edu.np
About this study
Official title: 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.
Read the 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.
- 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.
- 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.
- 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.
- 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
- Being tested
- Artesunate Injection
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate InjectionDrug
Also called Imatinib. Infliximab
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Artesunate | Experimental | Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414 Receives: Drug: Artesunate Injection |
| Imatinib | Experimental | Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414 Receives: Drug: Artesunate Injection |
| Infliximab | Experimental | Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414 Receives: Drug: Artesunate Injection |
| Local Standard of Care | No intervention | No other Intervention Given except the local standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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,
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
Measured: 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
To asses number of days ventilation requirement in the patient who are receiving study drug in addition to local standard of care
Measured: 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)
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
Measured: Number of Serious Adverse Effect (SAE) calculated from the day of randomization upto 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start6 Dec 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Same as that of WHO solidarity Trial Plus , Please refer to the ISRCTN18066414
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nepal Health Research Council
- Sponsor type
- Other government
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Dr. Pradip Gyanwali,MD, Nepal Health Research Council
- Investigators
- Dr Marie-Pierre Preziosi, Study director, WHO Solidarity Trial Plus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273242
- Sponsor's protocol ID
- Solidarity Trial Plus In Nepal
- Other IDs
- ISRCTN18066414
- Status last verified
- Mar 2022
- First submitted
- 10 Dec 2021
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05273242
- Acronym / sponsor ID
- Solidarity Trial Plus In Nepal
- Conditions
- COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nepal Health Research CouncilOther government
- Collaborators
- World Health Organization
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Same as that of WHO solidarity Trial Plus , Please refer to the ISRCTN18066414
| Arm | Type | Receives |
|---|---|---|
| Artesunate | Experimental | Drug: Artesunate InjectionPlease refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414 |
| Imatinib | Experimental | Drug: Artesunate InjectionPlease refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414 |
| Infliximab | Experimental | Drug: Artesunate InjectionPlease refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414 |
| Local Standard of Care | No intervention | –No other Intervention Given except the local standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artesunate InjectionAlso: Imatinib. Infliximab* 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. | Drug | Artesunate, Imatinib, Infliximab |
Primary outcome
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
3 secondary outcomes
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
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
Assessment of Serious adverse reactions (SAE)
Time frame: Number of Serious Adverse Effect (SAE) calculated from the day of randomization upto 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Marie-Pierre Preziosi study director
WHO Solidarity Trial Plus
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Artesunate Injection in people with COVID-19, run by Nepal Health Research Council at 5 sites in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Pradip Gyanwali, MD (4254220, prgyawali654@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.