covid19
Conditions
Brief summary
The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only.
Detailed description
The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only. After 7 days of treatment, the Investigator can extend the treatment duration for another 7 days at his/her discretion.
Interventions
DRUGNitazoxanide
Subjects will receive nitazonanide 600 mg TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.
DRUGPlacebo
Subjects will receive placebo TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.
Sponsors
Farmoquimica S.A.
Azidus Brasil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Subjects will be randomized to receive either nitazoxanide (n=150) or placebo (n=150)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Informed consent from patient or legal representative. * Subject of both genders (male and female not pregnant and not breastfeeding) aged over 49; * Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source; * Symptomatic subject with symptoms for up to 72 hours who does not require hospitalization, with signs and symptoms of acute respiratory viral infection characterized by a feverish sensation or fever, which may or may not be present at the time of the examination (which may be reported to the health professional), accompanied by cough or sore throat or runny nose or difficulty breathing and: i) Oxygen saturation ≥ 90%; ii) Risk classification for COVID-19 between low (A) or medium (B) (scores 1 to 19), according to the Brazilian Ministry of Health.
Exclusion criteria
* Participating in another RCT in the past 12 months; * 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 other antiviral drugs; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in signs and symptoms scale | 21 days | Symptoms will be assessed using a 5 point scale (1- excellent, 2- good, 3- fair, 4 - poor 5 - very poor). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 21 days | Number of participants with treatment-related adverse events |
| The proportion of subjects hospitalized after start of treatment and before the end of the study | 21 days | Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8) |
| The proportion of subjects that need mechanical ventilation after start of treatment and before the end of the study | 21 days | Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8) |
| Duration of symptoms | 21 days | Time required (days) to full symptom recovery |
| Rate of mortality within 21-days | 21 days | Evaluation of change in acute respiratory syndrome |
Outcome results
None listed