COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05126576

Hoffmann-La Roche

Not reported

2021-11-19

Suspended

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;France;Germany;Italy;Japan;Mexico;Portugal;Romania;South Africa;Switzerland;Turkey;Ukraine

Mild disease at enrollment

1: Mild disease at enrollment

1386

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"}]