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| Column | Value |
|---|---|
| Trial registration number | NCT04464408 |
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Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Nov. 8, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Nov. 8, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
dr.bosaeed@live.com |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-07-09 |
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Recruitment status
Last imported at : Nov. 8, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria patients must be eligible according to the following criteria for enrollment should be at least 18 years of age male or non-pregnant female (pregnancy testing is not mandatory. if the patient requests or is not sure, the study team will provide it) diagnosed with mild covid-19* confirmed by positive pcr test for sars-cov-2 at the time of recruitment, a result within the last five days patients have to be enrolled within 5 days of disease onset. exclusion criteria patients meeting any of the following criteria will be excluded from trial enrolment: patients with concomitant documented bacterial pneumonia established through positive sputum cultures patients who are pregnant or breastfeeding known sensitivity/allergy to favipiravir (if faviparavir was used for covid-19 in the patient previously for influenza) major comorbidities increasing the risk of study drug including hematologic malignancy advanced (stage 4-5) chronic kidney disease or dialysis therapy severe liver damage (child-pugh score c, ast> 5 times the upper limit) hiv gout/history of gout or hyperuricemia (two times above the uln) (6) having used favipiravir or participated in any other interventional drug clinical study within 30 days before the first dose of study drug (i.e., the patient received it for influenza previously) (7) the investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues) (8) clinical prognostic non-survival, palliative care, or in a deep coma and have no response to supportive treatment within three hours of admission. (9) hospitalized patients for mild, moderate, or severe covid-19 |
|
Exclusion criteria
Last imported at : March 2, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
King Abdullah International Medical Research Center |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Saudi Arabia |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
|
Total sample size
Last imported at : Nov. 8, 2021, 3:30 p.m. Source : ClinicalTrials.gov |
231 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
PCR negative |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |