COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04703608

Anna Roca, PhD

aroca@mrc.gm

2021-01-11

Unknown

RCT

Randomized

Adaptive

Blind label

single-center

Treatment

inclusion criteria: cohort 1: index case - individuals ≥ 5 years of age with confirmed covid19 mild disease or moderate pneumonia defined as: mild disease - influenza like illness, with any of the following symptoms cough, fever, headache, sore throat, nasal congestion/runny nose, body pains (myalgia), fatigue (malaise), diarrhoea, abdominal pain, anorexia, nausea or vomiting without evidence of pneumonia or hypoxia moderate pneumonia -clinical signs of pneumonia (fever, cough, dyspnoea, fast breathing) with no need for supplemental oxygen (oxygen saturation ≥90%% on room air or rr between 20 and 30bpm). household contacts - individuals ≥ 5 years of age living in the same household with the index cases from cohort 1 will be offered to participate into the study. living in the same household is defined as those individuals who are planning to sleep in and eat from same 'cooking pot' during the following 2 weeks. cohort 2: individuals ≥12 years of age with suspected or confirmed covid-19 associated severe pneumonia defined as signs of pneumonia (fever, cough, dyspnoea or fast breathing) plus one of: oxygen saturation (spo2) <90% on room air or respiratory rate > 30 breaths/minute suspected covid-19 disease is defined as clinically or radiologically suspected as determined by the most senior clinician available: clinically suspected signs and symptoms of pneumonia (as defined above) and patient living in or recent travel to region with community transmission or close contact with known covid-19 patient and no alternative diagnosis to explain the clinical picture or radiologically suspected typical radiological signs of covid-19 on chest x-ray or lung ultrasound

- pregnant women will be excluded from both cohort 1 and cohort 2. patients with allergies to the investigational products will be excluded cohort 1 (ivermectin) lactating mothers will be excluded cohort 2 (aspirin): - taking aspirin or other non steroidal anti-inflammatory drugs for any reason. - any bleeding disorder (e.g. frequent nose bleeds, haemophilia) - active or recurrent peptic ulcer disease (defined as currently on triple therapy or had more than 1 course of triple therapy in the past 12 months. do not count symptoms of gastritis or on omeprazole as peptic ulcer disease) - current active gastrointestinal haemorrhage - severe liver disease or severe kidney disease (severe liver disease defined as cirrhosis with portal hypertension and history of variceal bleeding; severe kidney disease defined as stage 4/5 kd, egfr <30ml/min) - gout - suspected intra-cerebral haemorrhage - diagnosed with a stroke on this admission

3

London School of Hygiene and Tropical Medicine

5

100

Gambia

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

1200

Cohort 1 Household contacts: Percentage of HH members that get infected with SARS-CoV-2 [Time frame 14 days];Cohort 1 Index Case: Percentage of patients with COVID-19 associated mild disease/moderate pneumonia progressing to severe pneumonia [Time frame 14 days];Cohort 2: Percentage of COVID-19 associated severe pneumonia patients worsening their condition [Time frame at discharge or day 28 (whichever is first)]

None

Phase 3

[{"arm_notes": "Cohort 2", "treatment_id": 129, "treatment_name": "Aspirin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Cohort 1", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Cohort 1/Cohort 2", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]