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Trial - NCT04613271


Column Value
Trial registration number NCT04613271
Full text link
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04613271

First author
Last imported at : March 11, 2023, 8 p.m.
Source : ClinicalTrials.gov

Armedy Ronny Hasugiana

Contact
Last imported at : March 11, 2023, 8 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-11-03

Recruitment status
Last imported at : March 11, 2023, 8 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: adult patients 18 years - 59 years confirmation of covid-19 based on the results of the real time pcr (rtpcr) examination for sars-cov-2 less than 7 days before the first day of taking the drug patients with mild-moderate clinical manifestations were admitted to the hospital designated by the physician according to the operational definition of the study protocol have not received covid-19 antiviral therapy consciously and voluntarily participate in research

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

pregnant and lactating women allergy history to favipiravir and standard hospital drugs patients with uric acid examination values above normal male> 7 mg / dl; women> 5.7 mg / dl patients with a history of prolonged ecg / arrhythmia / qt disorders cannot swallow drug

Number of arms
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Ina-Respond

Inclusion age min
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

59

Countries
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Indonesia

Type of patients
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : March 11, 2023, 8 p.m.
Source : ClinicalTrials.gov

130

primary outcome
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Clinical improvement measured by no sign & symptom for 3 days and RTPCR negative

Notes
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Nov. 4, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1508, "treatment_name": "Azithromycin+favipiravir", "treatment_type": "Antibiotics+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 165, "treatment_name": "Azithromycin", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}]