Last updated: June 3, 2021
Sponsor: London School of Hygiene and Tropical Medicine
Overall Status: Active - Recruiting
Phase
3
Condition
Pneumonia
Covid-19
Treatment
N/AClinical Study ID
NCT04703608
LEO 22628
Ages > 5 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Cohort 1: Index case - Individuals ≥ 5 years of age with confirmed COVID19 mild disease or moderatepneumonia 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 withoutevidence of pneumonia or hypoxia
- Moderate pneumonia -Clinical signs of pneumonia (fever, cough, dyspnoea, fastbreathing) with no need for supplemental oxygen (oxygen saturation ≥90%% on room airor RR between 20 and 30bpm). Household contacts - Individuals ≥ 5 years of age living in the same household with theindex cases from cohort 1 will be offered to participate into the study. Living in the samehousehold 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 severepneumonia defined as signs of pneumonia (fever, cough, dyspnoea or fast breathing) plus oneof: oxygen saturation (SpO2) <90% on room air OR respiratory rate > 30 breaths/minute Suspected COVID-19 disease is defined as clinically or radiologically suspected asdetermined by the most senior clinician available:
- Clinically suspected Signs and symptoms of pneumonia (as defined above) AND patientliving in or recent travel to region with community transmission OR close contact withknown 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 lungultrasound
Exclusion
Exclusion Criteria:
- Pregnant women will be excluded from both Cohort 1 and Cohort 2. Patients withallergies 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 orhad more than 1 course of triple therapy in the past 12 months. Do not count symptomsof gastritis or on omeprazole as peptic ulcer disease)
- Current active gastrointestinal haemorrhage
- Severe liver disease or severe kidney disease (severe liver disease defined ascirrhosis with portal hypertension and history of variceal bleeding; severe kidneydisease defined as stage 4/5 KD, eGFR <30ml/min)
- Gout
- Suspected intra-cerebral haemorrhage
- Diagnosed with a stroke on this admission
Study Design
Total Participants: 1200
Study Start date:
January 22, 2021
Estimated Completion Date:
July 31, 2022
Study Description
Connect with a study center
Mrcg@Lshtm
Fajara,
GambiaActive - Recruiting
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