COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05155527

Not reported

Not reported

2021-12-13

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: adult patient age between 18-65 years old has confirmed sars-cov-2 infection by rt-pcr method using sample collected from nasopharyngeal swab (np) and oropharyngeal swab (op) with ct value in either one of the following cases ct ≤ 26 if the subject has rt-pcr performed as part of screening procedures ct ≤ 24 if the subject has had rt-pcr performed before admission and the time between the sample collection for rt-pcr and randomization is ≤ 24 hours has been admitted for medical care at the investigational sites in case of symptomatic patient, date of symptoms onset is ≤ 7 days prior to randomization. in case of asymptomatic patient, the first date of positive result from rt-pcr or antigen test kit for sars-cov-2 is ≤ 7 days prior to randomization. qualified for the criteria to receive favipiravir for covid-19 treatment according to guidelines on clinical practice, diagnosis, treatment, and prevention of healthcare-associated infection for covid-19 in thailand in either one of the following cases will start receiving favipiravir during the study period or has received favipiravir no more than 24 hours before receiving the investigational drug asymptomatic or has mild to moderate covid-19 as defined in section 7.2.2. willing to participate in the study and able to provide written informed consent women of childbearing potential must agree to either abstinence or use at least one primary form of contraception from the time of screening through d28.

has severe or critical covid-19 as defined in section 7.2.2. bedridden (totally confined to bed) has elevated alanine aminotransferase (alt) or aspartate aminotransferase (ast) over 3 times the upper range of normal limits, or history of liver cirrhosis females only: currently pregnant, as determined by positive β-human choriogonadotropin (hcg) test in urine, or breast-feeding receiving other potential drugs for covid-19 treatment prior to randomization including remdesivir, nitazoxanide, chloroquine, hydroxychloroquine, azithromycin, lopinavir-ritonavir, famotidine, tocilizumab, baricitinib (except favipiravir) received ivermectin within 1 month prior to the randomization receiving other immunosuppressive or immunomodulatory drugs for the treatment of other conditions (not including topical steroids) history of hypersensitivity to ivermectin or favipiravir or any components of the drugs receiving medications that increase gamma-aminobutyric acid (gaba) potentiating activity such as barbiturates, benzodiazepines, sodium oxybate, valproic acid, or receiving medications that prevent or inhibit the p-glycoprotein transport system such as amiodarone, carvedilol, clarithromycin, cyclosporine, erythromycin, itraconazole, ketoconazole, quinidine, ritonavir, tamoxifen, verapamil, amprenavir, clotrimazole, phenothiazines, rifampin, st. john's wort etc. has history of hereditary xanthinuria has hypouricemia (serum uric acid ≤ 1 mg/dl), uncontrolled gout or history of xanthine urolithiasis participating in other clinical trials or participated in other clinical trials in a period of one month or less than 5 half-lives of the study drug before screening

2

Mahidol University

18

65

Thailand

Mild disease at enrollment

1: Mild disease at enrollment

200

The rate of SARS-CoV-2 viral clearance

None

Phase 2

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