Clinical trial: Prevention and Treatment for COVID -19 (Severe Acute Respiratory Syndrome Coronavirus 2 SARS-CoV-2) Associated Severe Pneumonia in the Gambia (NCT04703608)

Eligibility criteria:
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:

          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

        Exclusion Criteria:

          -  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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Contradiction