COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04468087

Israel Maia, PhD

ismaia@ext.hcor.com.br

2020-07-13

Completed

RCT

Randomized

Adaptive

Blind label

single-center

Treatment

inclusion criteria: adults (≥ 18 years) hospitalized with covid-19: sars-cov-2 positive rt-pcr or antigen test typical clinical history and chest ct with typical findings, pending rt-pcr for sars-cov-2 symptom duration <= 9 days spo2 <= 94% in room air or need for supplemental oxygen to maintain spo2> 94% the patient consents to participate in the study and is willing to comply with all study procedures, including the collection of virology samples

patients in need of respiratory support with invasive mechanical ventilation; alanine transaminase (alt) or aspartate transaminase (ast) > 5 times the upper limit of normal; total bilirubin > 2 mg/dl; platelets <50,000 cel/l; total neutrophil count <750 cell/l; renal dysfunction (estimated glomerular filtration rate [egfr] <30 ml / min / 1.73 m2, using the mdrd or ckd-epi method); and pre-defined renal failure stage 3 according to akinx classification with serum creatinine> 4 mg / dl or patient already on renal replacement therapy; previously known liver disease (liver cirrhosis), defined as a report by the participant or written in the respective cirrhosis chart, esophageal varices, or the presence of clinical ascites on examination; decompensated congestive heart failure defined as the presence of dyspnea, edema of the lower limbs or rales on pulmonary auscultation, jugular turgency or chest x-ray with signs of pulmonary congestion; pregnant or breast feeding patients; known allergy or hypersensitivity to any study drug; hepatitis c carrier (hcv rna positive), active hepatitis b (positive surface antigen in the past), or hiv (elisa and confirmatory western blot in the past). new screening tests are not required; patients currently using nucleoside or nucleotide analog drugs for any indication; corrected q interval t> 480 on the electrocardiogram; heart rate <55 bpm; patients in use or who recently used (<90 days) amiodarone; women of childbearing potential and men with a partner of childbearing potential who do not agree to use two contraceptive methods (including barrier method) for 100 days.

4

Hospital do Coracao

18

90

Brazil

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

256

Phase II second step: Change in the slope of SARS-COV 2 viral load;Phase II first step: Change in the slope of SARS-COV 2 viral load;Phase III: Number of free days from respiratory support

None

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 135, "treatment_name": "Atazanavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 373, "treatment_name": "Daclatasvir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1478, "treatment_name": "Daclatasvir+sofosbuvir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]