COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04435314

Not reported

Not reported

2020-06-17

Withdrawn

RCT

Randomized

Parallel

Blind label

unclear

Prevention

inclusion criteria: - informed consent from patient or legal representative. - subject of both genders (male and female not pregnant and not breastfeeding) aged 18 years or over; - subject that lives in a vulnerable community; - subject that were in direct contact with confirmed cases of sars-cov-2 infection, as they live or work directly with index patients; - not showing symptoms compatible with covid-19 and and that do not have a positive rt-pcr test in a nasopharyngeal swab sample before randomization; - participant capable of understanding and fulfilling all activities planned for the study; - in use of an acceptable method of contraception throughout the study.

- participating in another rct in the past 12 months; - positive pcr result for covid-19 during screening; - history of infection confirmed by sars-cov-2; - present symptoms suggestive of sars-cov-2 infection; - presence of comorbidities, which have a contraindication to the use of the study product, not being restricted to: - hiv or htlv virus infection; - chronic hepatitis c (hcv) treated with direct antiviral drugs; - liver failure; - severe renal failure, including dialysis; - present hypersensitivity to the study product (nitazoxanide), as well as to related compounds; - concomitant administration of drugs that may interact with the product under study (nitazoxanide); - participants who underwent treatment with antivirals and / or antiparasitic drugs in the last 30 days; - subject in antineoplastic treatment with chemotherapy or radiation therapy; - subject with severe autoimmune diseases in immunosuppression; - transplanted participants; - pregnant or lactating women; - any other clinical condition that is deemed by the investigator to be an imminent risk to the health and life of the subject.

2

Azidus Brasil

18

100

None

Close contacts to covid patients

N/A

0

The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study

None

Phase 2

[{"arm_notes": "", "treatment_id": 888, "treatment_name": "Nitazoxanide", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]