Platform Randomised trial of INterventions against COVID-19 In older peoPLE

INTERVENTION: Trade Name: Plaquenil‐Hydroxychloroquine Product Name: Plaquenil‐Hydroxychloroquine Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Hydroxychloroquine Sulfate 200 mg Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Trade Name: Azithromycin Product Name: Azithromycin Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Azithromycin 250 mg or 500 mg Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ Trade Name: Doxycycline Product Name: Doxycycline Pharmaceutical Form: Capsule, hard INN or Proposed INN: Doxycycline hyclate equivalent to 100mg of Doxycycline base Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ CONDITION: Suspected COVID‐19 ; MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862 Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: To assess the effectiveness of trial treatments in reducing the need for hospital admission or death for patients aged =50 years with serious comorbidity, and aged =65 with or without comorbidity and suspected COVID‐19 infection during time of prevalent COVID‐19 infections. Primary end point(s): Hospital admission or mortality related to suspected COVID‐19. Secondary Objective: To explore whether trial treatment reduces; 1) Duration of severe symptoms; 2) Time taken to resumption of usual daily activities; 3) Contacts with the health services ; 4) Consumption of antibiotics; 5) Hospital assessment not leading to admission; 6) Oxygen administration; 7) Intensive Care Unit admission ; 8) Mechanical ventilation; 9) To determine if effects are specific to those with the infections syndrome but who test positive for COVID‐19; 10) Duration of hospital admission ; Timepoint(s) of evaluation of this end point: Within 28 days. SECONDARY OUTCOME: Secondary end point(s): To explore whether trial treatment reduces the following:; ; 1. Duration of severe symptoms; 2. Time taken to resumption of usual daily activities; ; Measured by daily online symptoms score and the day the patient reports they returned to usual activities.; ; 3. Contacts with health services; ; Reported by patients and captured by reports of patients‘ medical records where the practice is a member of RSC.; ; 4. Consumption of antibiotics; ; Measured using bi‐weekly reports from participants primary care medical records.; ; 5. Hospital assessment not leading to admission; 6. Oxygen administration; 7. Intensive Care Unit admission ; 8. Mechanical ventilation; ; All measured using patient report/carer report/medical record in primary care and hospital care. HES/ONS data linkage after 28 days where patients have been assessed in hospital. ; ; 9. To determine if effects are specific to those with the infections syndrome but who test positive for COVID‐19.; ; Swab results for COVID‐19 will indicate an “Intention to Treat Infectedâ€? group within the overall cohort for sub analysis (Swab result available once processed from GP record and from PHE laboratory).; ; 10. Duration of hospital admission; Measured using patient report/carer report/medical record in primary care and hospital care. HES/ONS data linkage after 28 days where patients have been assessed in hospital. ; ; ; Timepoint(s) of evaluation of this end point: Within 28 days INCLUSION CRITERIA: • Participant is willing and able to give informed consent for participation in the study. • Participant is willing to comply with all trial procedures • Onset of symptoms of possible COVID‐19 in the community (continuous cough and/or high temperature) within 7 days of inclusion • Patients aged =50‐64 years with any of the following listed comorbidities: ‐ known weakened immune system due to a serious illness or medication (e.g. chemotherapy) ‐ known heart disease ‐ known asthma or lung disease ‐ known diabetes not treated with insulin ‐ known mild hepatic impairment ‐ known stroke or neurological problem OR • Patients aged =65 with or without comorbidity Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for