covid19
Conditions
Brief summary
This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.
Detailed description
This is pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19. The aim is to demonstrate a decrease in hospital related complications among patients who are hospitalized with moderate COVID-19 by treating them with nitazoxanide BID 600 mg for 7 days on top of standard care compared to placebo on top of standar care.. Therefore, patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive either nitazoxanide 600 mg BID or Placebo.
Interventions
DRUGNitazoxanide
Patients will receive nitazoxanide 600 mg BID for 7 days.
DRUGPlacebo
Patients will receive matching placebo BID for 7 days.
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
Patients will be randomized to receive either nitazoxanide 600 mg BID or Placebo (1:1)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed consent from patient or legal representative. 2. Male or female, aged ≥ 18 years; 3. Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase 4. chain reaction (RT-PCR) from any diagnostic sampling source; 5. Hospitalized for up to 48h with signs of respiratory failure with or without non-invasive ventilation and i. Oxygen saturation \<98%; 7\. Negative result for pregnancy test (if applicable).
Exclusion criteria
1. Participating in another RCT in the past 12 months; 2. Known allergy to nitazoxanide 3. Severely reduced LV function; 4. Severely reduced renal function; 5. Pregnancy or breast feeding; 6. Diagnosis of any other active infection (viral, bacterial, fungal or caused by another pathogen, except the one studied in the trial); 7. History of HIV 1 and/or 2 (Anti-HIV-1,2) and/or HTLV I and II positive; 8. Ongoing antineoplastic treatment with chemotherapy or radiation therapy; 9. Diagnose of severe autoimmune diseases in immunosuppression; 10. Transplanted patients; 11. Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need of mechanical ventilation | 14 days | Evaluation of change in acute respiratory syndrome using 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the pulmonary condition | Baseline, Day 7 and Day 14 | Evaluation of change in oximetry, respiratory rate and need for oxygen therapy |
| Change in Clinical Condition | Baseline, Day 7 and Day 14 | Evaluation of change in the following symptoms: cough, headache, myalgia and fever, level of consciousness and organ dysfunction |
| Change in tomographic pulmonary condition | Baseline, Day 7 | Evaluation of change in chest CT |
| Rate of mortality within 14-days | 14 days | Evaluation of change in acute respiratory syndrome |
| Change in inflammatory markers | Baseine, Day 7, Day 14 | Evaluation of change in inflammatory markers d-dimer and IL-6 |
Countries
Brazil
Contacts
Primary ContactFlorentino de Araujo Cardoso Filho, MD, PhD
Backup ContactLuciana Ferrara
Outcome results
None listed