Prevention and Treatment for COVID -19 (Severe Acute Respiratory Syndrome Coronavirus 2 SARS-CoV-2) Associated Severe Pneumonia in the Gambia

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/A

Clinical Study ID

NCT04703608
LEO 22628
  • Ages > 5
  • All Genders

Study Summary

The trial aims to assess the impact of cheap, licenced and widely available investigational products on the natural history of SARS-CoV-2 infection in 2 groups of patients - those with mild or moderate pneumonia (Cohort 1) and those with severe pneumonia (Cohort 2), through randomisation to non-identical placebo or intervention arm.

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:
  1. 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
  2. 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

The trial is adaptive in design, with the option to change the investigational products should evidence change on the benefits/harms of the interventions being trialed.

Cohort 1. Currently index cases with mild COVID-19 or moderate pneumonia will be randomized to ivermectin 0.3-0.4mg/Kg daily for 3 days (arms 1 and 2) or non-identical placebo (arm 3). Index case randomization will also include HH members who will be treated with ivermectin 0.3-0.4mg/Kg daily for 3 days (arm 1) or non-identical placebo (arms 2 and 3). All households will receive a preventative package (containing soap, bleach, cloth facemasks and instructions on their use).

Cohort 2. Patients admitted to hospital meeting WHO criteria for severe COVID-19 pneumonia will be randomized to aspirin 150mg daily or non-identical placebo for 28 days or until hospital discharge (whichever is sooner). Other care will follow National guidelines.

The study will be conducted at multiple sites in The Gambia, with the option to recruit from other West African countries should this be necessary (subject to further local ethical review/s).

Connect with a study center

  • Mrcg@Lshtm

    Fajara,
    Gambia

    Active - Recruiting

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