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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN18066414 | Registry Identifier | ISRCTN |
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| Name | Class |
|---|---|
| World Health Organization | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artesunate | Experimental | Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414 |
|
| Imatinib | Experimental | Please refer to the WHO solidarity Trial Plus Protocol ISRCTN18066414 |
|
| Infliximab | Experimental | Please 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artesunate Injection | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Pradip Gyanwali, MD | Contact | 4254220 | prgyawali654@gmail.com | |
| Prof. Dr. Janak Koirala, MD/MPH | Contact | 9818762117 | clinicaltrialnepal@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Marie-Pierre Preziosi | WHO Solidarity Trial Plus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chitwan Medical College | Active, not recruiting | Bharatpur | Bagmati | Nepal | ||
| Civil Service Hospital |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077332 | Artesunate |
| ID | Term |
|---|---|
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
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Same as that of WHO solidarity Trial Plus , Please refer to the ISRCTN18066414
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|
|
| 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 | 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 | Number of Serious Adverse Effect (SAE) calculated from the day of randomization upto 28 days |
| Recruiting |
| Kathmandu |
| Bagmati |
| Nepal |
|
| Patan Academy of Health Sciences | Not yet recruiting | Lalitpur | Bagmati | Nepal |
|
| Lumbini Provincial Hospital | Active, not recruiting | Butwal | Lumbini | Nepal |
| Narayani Hospital | Active, not recruiting | Birgunj | Madhesh | Nepal |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009930 |
| Organic Chemicals |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |