Clinical TrialID 8414
Effectiveness and Safety of Quinine Sulfate as add-on Therapy for COVID-19 in Hospitalized Adults in Indonesia ( DEAL-COVID19 )
NCT05808231
COVID-19
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8414
- Evidence Id
- 8414
- Core Evidence Id
- 8414
- Source Clinical Trial Id
- 8412
- Herb2 Clinical Trial Id
- HBCT008412
- Nct Id
- NCT05808231
- Title
- Effectiveness and Safety of Quinine Sulfate as add-on Therapy for COVID-19 in Hospitalized Adults in Indonesia ( DEAL-COVID19 )
- Status
- Recruiting
- Phase
- Study Result
- No
- Study Condition
- COVID-19
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
- Intervention
- DRUG: Standard of Care + Quinine Sulfate|DRUG: Standard of Care
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Supportive_Care
- Gender
- All
- Age
- Adult
- Enrollment
- 100
- Outcome Measure
- The clinical condition of the subjects assessed on a 7-point ordinal scale, The clinical condition of the subjects was assessed until day 10 using a 7-point ordinal scale, as follows: 1. Death 2. Hospitalization, with invasive mechanical ventilation or ECMO 3. Hospitalization, with non-invasive ventilation or high-flow oxygen device; 4. Hospitalized, requires additional oxygen; 5. Hospitalized, does not require additional oxygen; 6. Not hospitalized, activity restrictions; 7. No hospitalization, no activity restrictions, From the date of randomization until the date of first documented subject discharge or death from any cause, assessed up to 10 days
- Sponsor Collaborator
- Universitas Padjadjaran|National Research and Innovation Agency of Indonesia|Prodia Diacro Laboratories P.T.
- Funded By
- OTHER
- Location
- Gatot Soebroto Army Central Hospital (RSPAD), Jakarta, DKI Jakarta, 10410, Indonesia|Dr. Hasan Sadikin Central General Hospital (RSHS), Bandung, West Java, 40161, Indonesia
- Other Id
- Pharm-202005.12
- Start Date
- 2021-04-26
- Primary Completion Date
- 2022-06-30
- Completion Date
- 2023-05-31
- First Posted
- 2023-04-11
- Results First Posted
- Last Update Posted
- 2023-04-11
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05808231
- Title Cn
- Title En
- Effectiveness and Safety of Quinine Sulfate as add-on Therapy for COVID-19 in Hospitalized Adults in Indonesia ( DEAL-COVID19 )
- Bilingual Status
- semi_complete