COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04889040

Not reported

global-roche-genentech-trials@gene.com

2021-05-17

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - positive sars-cov-2 diagnostic test (rt-pcr or validated rapid antigen test) ≤72 hours prior to randomization - at least three of the following symptoms of at least moderate (score ≥2 as per covid-19 symptom diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea. - has symptoms consistent with mild or moderate covid-19, as determined by the investigator, with onset ≤5 days before dosing on day 1

- clinical signs indicative of covid-19 illness requiring hospitalization - admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to covid-19 - in the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization - treatment with an investigational drug within 5 half-lives or 3 months (whichever is longer) of randomization - treatment with a covid-19 therapeutic agent including, but not limited to, other direct or indirect acting antivirals against sars-cov-2 (such as remdesivir or favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal antibodies against sars cov-2 or interleukin 6 (il-6), intravenous immunoglobulin or other eua-approved treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit - concomitant use of p-glycoprotein inhibitors or inducers listed as prohibited therapy in the protocol - known allergy or hypersensitivity to components of study drug - abnormal laboratory test results at screening - requirement of any prohibited medications during the study - other known active viral or bacterial infection at the time of screening, such as influenza - any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study - covid-19 vaccination within ≤ 40-days prior to enrollment (second dose if applicable)

2

Hoffmann-La Roche

12

100

Argentina;Belgium;Brazil;Denmark;Germany;Japan;Mexico;Portugal;Romania;Switzerland;Turkey;Ukraine

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

216

Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 hours)

None

Phase 3

[{"arm_notes": "", "treatment_id": 134, "treatment_name": "At-527", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]