COVID-19 trials registries data warehouse

https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=13461

Effua Usuf

Effua.Usuf@lshtm.ac.uk

2020-10-27

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Cohort 1 Inclusion Individuals = 5 years of age with confirmed COVID19 mild disease or moderate pneumonia defined as: - Mild disease - Influenzae like illness, with any of the following symptoms cough, fever, headache, sore throat, nasal congestion/runny nose, body pains (myalgia), fatigue (malaise), diarrhea, 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). HH members from Cohort 1 – Individuals > 5 year of age living in the same HH with the index cases from cohort 1 will be offered to participate into the study. Living in the same HH is defined as those individuals who are planning to sleep in and eat from same compound 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: 1. 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 2. Radiologically suspected Typical radiological signs of COVID-19 on chest X-ray or lung ultrasound

Cohort 1 Pregnant women will be excluded from both Cohort 1 if the drug is IVM and . Individuals will be excluded into the study if: - Known contra-indication or allergy to study drugs Cohort 2 If the drug is Aspirin. Individuals will be excluded into the study if: - Known contra-indication or allergy to study drugs Some clinical characteristics will exclude participants from some of the severe pneumonia arms: PaTS-COVID Trial: Protocol Version 1.3_17 August 2020 o Patients already on steroids will be excluded from the dexamethasone arm if applicable o Active untreated or inactive tuberculosis for the deaxamethasone arm if applicable o Known bleeding disorder for aspirin if applicable o Prolonged QTc – excluded from azithromycin if applicable

3

Medical Research Council Unit The Gambia at LSHTM

5

100

Gambia

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

1200

Cohort 1 Percentage of patients with COVID-19 associated mild disease/moderate pneumonia progressing within 14 days after recruitment into severe pneumonia; defined as per most recent adapted WHO definition15 as follows : Clinical signs of pneumonia plus: • Oxygen saturation (SpO2) <90% on room air OR • Respiratory rate > 30 breaths/min Note: if WHO definitions change over the course of the recruitment phase of the trial; the trial definitions will be adapted accordingly. 2. Cohort 1 HH contacts - % of HH members that get infected with COVID19 during the 14 days following recruitment (defined as those RT-PCR and IgM/IgG negative at day 1 who become positive either by RT-PCR or IgM/IgG by day 14) 3. Cohort 2 - Percentage of COVID-19 associated severe pneumonia patients meeting the criteria of failure defined as worsening their condition over a 24h period (Increase by 1 point from baseline on a 7-point ordinal scale) or who die during hospitalization. The 7-point ordinal scale consists of: 1) Not hospitalised 2) Hospitalised – not on oxygen; no longer needs medical care 3) Hospitalised – not on oxygen; needs ongoing medical care 4) Hospitalised – on or requiring supplemental oxygen given by nasal cannula or face mask to maintain SpO2 and/or respiratory rate within normal range for age 5) Hospitalised – on or requiring non-invasive ventilation or high-flow oxygen devices to maintain SpO2 and/or respiratory rate within normal range for age 6) Hospitalised – on or requiring invasive ventilation OR failure of NIV/high flow oxygen devices to maintain SpO2 and/or respiratory rate within normal range for age 7) Death

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 129, "treatment_name": "Aspirin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]