TCTR20200514001
Completed
Phase 2
An Investigation of the Efficacy and Safety of Favipiravir in COVID 19 Patients without Pneumonia
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Faculty of Medicine, Siriraj Hospital
- Enrollment
- 93
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\)Age: 18 to 74 years (at the time of informed consent)
- •(2\)Gender: Male or female
- •(3\)Patients who meet all of the following criteria 1\), 2\), and 3\) at the time of enrollment
- •1\)Patients with SARS\-CoV\-2\-positive airway specimens such as nasopharyngeal swab, nasal aspirate, airway aspirate, or saliva by RT\-PCR test
- •2\)Patients without lung lesions on chest images that compatible with pneumonia
- •3\)Patients with a fever more than or equal to 37\.5 degree celsius or symptoms of COVID\-19 (including cough, malaise or fatigue, headache, sore throat, nasal congestion, chill or sweating, muscle or joint pain, chest pain, diarrhea, loss of taste and loss of smell)
- •(4\)For premenopausal female patients, patients who have been confirmed to be negative on a urine pregnancy test before administration of the study drug
- •(5\)Patients who understand the contents of this study and are able to provide written consent by themselves without assistance
Exclusion Criteria
- •(1\)Fever (more than or equal to 37\.5 degree celsius) more than 10 days after the onset of fever
- •(2\)Patients who have the following clinical symptoms 1\), 2\) and 3\)
- •1\)SpO2 less than 95% without oxygen therapy
- •2\)Respiratory rate more than 24 breath/min
- •3\)Blood pressure (SBP/DBP) less than 90/60 mmHg
- •(3\)Patients who show increased procalcitonin levels before the start of study drug administration and are suspected to have concurrent bacterial infection
- •(4\)Patients with suspected concomitant fungal infections prior to initiation of study drug (e.g., 1\-3\-beta glucan: 30 pg / ml or higher)
- •(5\)Patients who show, for example, abnormal NT\-pro BNP levels (100 pg/mL or higher etc.) and/or are suspected to have concurrent congestive heart failure
- •(6\)Patients with severe hepatic impairment equivalent to Grade C on Child\-Pugh classification
- •(7\)Patients with renal impairment requiring dialysis
Outcomes
Primary Outcomes
Not specified
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