Prevention and Treatment of COVID19 Associated Severe Pneumonia in The Gambia: A single blind - Randomized Trial COVID-19

Medical Research Council Unit The Gambia at LSHTM0 sites1,200 target enrollmentOctober 27, 2020

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Medical Research Council Unit The Gambia at LSHTM
Enrollment: 1200
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 27, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Medical Research Council Unit The Gambia at LSHTM

Eligibility Criteria

Inclusion Criteria

•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
•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
•2\. Radiologically suspected
•Typical radiological signs of COVID\-19 on chest X\-ray or lung ultrasound

Exclusion Criteria

•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
•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