COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
1. Loratadine + famotidine plus usual care: loratadine 10 mg tablet once a day swallowed whole with water every morning and famotidine 40 mg tablet once a day swallowed whole with water every morning.
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for ALL participants: 1. Participants capable of giving informed consent 2. Age 18 years and above 3. Clinical parameters: persistent signs and symptoms for a period of 4 weeks or longer in duration post-COVID-19 infection (either by test result or symptomology). Presenting at their first referral first visit to a participating Long COVID clinic pathway. 4. Able to read or understand English or have a relative/family member able to read/understand English to facilitate participation (essential for patient-reported outcome measures at follow-up time points and virtual contact) 5. Not enrolled in any other interventional study where study intervention/activities may affect outcome measures (patients enrolled in purely observational studies can be included) Additional inclusion criteria for the nested, platform randomised drug trial (to be eligible participants must meet all above criteria and all those below). Note: Potential participants with drug-specific contraindications for any arm, including interactions of pre-prescribed essential medication will be consented for data collection but will be excluded from the drug study. 6. Females of childbearing potential (see definition below) must be willing to use an acceptable effective method of contraception during the treatment with the IMP and for a further 30 days after the last dose. Such methods include: 6.1. Combined (oestrogen- and progestogen-containing) hormonal contraception: 6.1.1. Oral 6.1.2. Intravaginal 6.1.3. Transdermal 6.2. Progestogen-only hormonal contraception 6.2.1. Oral 6.2.2. Injectable 6.2.3. Implantable 6.3. Intrauterine device (IUD) 6.4. Intrauterine hormone-releasing system (IUS) 6.5. Bilateral tubal occlusion 6.6. Vasectomised partner 6.7. Male or female condom with spermicide 6.8. Cap, diaphragm or sponge with spermicide 6.9. Sexual abstinence; only true abstinence is acceptable i.e. when this is in line with the preferred and usual lifestyle of the participant). (periodic abstinence, declaration of abstinence during exposure to IMP and withdrawal are not accepted methods of contraception). For the purpose of this trial, a female is considered of childbearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. 7. Male participants must be willing to use condoms during IMP treatment and for a further 90 days after the last dose of trial IMP to protect their female partner from becoming pregnant 8. Patients on pre-existing treatments for the same drug classes MUST undergo a 7-day washout period before being randomised. (Patients will be assessed, and if safe to do so, exclude that medication for 7 days, asked if they would be willing to undergo a washout period of at least 7 days before being randomised)
Exclusion criteria
Exclusion criteria: Exclusion criteria for ALL participants: 1. Previously hospitalised for COVID-19 infection 2. Previously referred to a long COVID clinic Exclusion criteria for nested, adaptive randomised drug trial: 3. Females who are pregnant, planning pregnancy or breastfeeding 4. Known hypersensitivity to any of the study drugs or their excipients 5. Currently taking any of the following drugs: probenecid, sucrafate, isocarboxazid, phenylzine, tranylcypromine of any other CNS depressant (such as diphenhydramine, dextromethorphan, or pseudoephedrine) (contraindications to famotidine/loratadine), amiodarone, aprepitant, atanazavir, atorvostatin, azithromycin, bezafibrate,ciclosporin, ciprofibrate, clarithromycin, cobicistat, croztibib, darunavir, diltiazem, dronedarone, eliglustat, erythromycin, fenobibrate, fluconazole, fluvastatin, fosamprenavir, gemfibrozil, idelalisib, imatibib, isavuconazole, itraconazole, ketoconazole, letermovir, lopinavir, netupitant, nilotinib, posaconazole, pravastatin, ranolazine, ritonavir, rosuvastatin, simvastatin, tipranavir, velpatasvir, vemurafenib, venetoclax, verapamil, voriconazole (contraindications to colchicine), acalabrutinib, aceclofenac, acenocoumarol, alprostadil, alteplase, argatroban, aspirin, axitinib, beniparin, benzydamine, bevacizumab, bismuth, bivalirudin, bosutinib, bromfenac, cabozantinib, cangrelor, caplacizumab, celecoxib, cilostazol, clopidogrel, cobimetinib, dabigatran, dalteparin, danaparoid, dasatinib, dexkeptorofen, diclofenac, dipyridamole, enoxaparin, epoprostenol, eptifibatide, etodolac, etoricoxib, flurbiprofen, heparin, ibrutanib, ibuprofen, iloprost, imatinib, indomethacin, inotersen, ketoprofen, ketorolac, levatinib, mefenamic acid, meloxicam, nabumetone, naproxen, nicotinic acid, nintenanib, parecoxib, pazopanib, phenazone, phenindione, piroxicam, ponatinib, prasugrel, regorafenib, ruxolitinib, sorafenib, streptokinase, sulindac, sunitinib, tenecteplase, tenoxicam, tiaprofenic acid, ticagrelor, tinzaparin, tirofiban, tolfenamic acid, trametinib, traztuzumab emtansine, trprostinil, urokinase, volanesorsen, warfarin (contraindications to rivaroxaban) 6. No history or presenting symptomology suggestive of renal failure/insufficiency (eGFR <30 ml minute) on the basis of blood investigations (eGFR) within the last 6 months and clinical assessment 7. Severe liver dysfunction on the basis of blood investigations within the last 6 months (liver function and coagulation) and clinical assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome as of 11/06/2026: Fatigue measured using the Fatigue Assessment Scale at 12 weeks Previous primary outcome: Fatigue measured using the Fatigue Assessment Scale at baseline, 12 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcomes as of 11/06/2026: 1. Fatigue measured using the Fatigue Assessment Scale at 24 weeks 2. Health-related quality of life is measured using the EQ-5D-5L at 12 and 24 weeks 3. Mental health is measured using the Generalised Anxiety Disorder Assessment (GAD-7) at 12 and 24 weeks 4. Depression is measured using Patient Health Questionnaire (PHQ-9) at 12 and 24 weeks 5. Dyspnoea is measured using MRC Dyspnoea Score at 12 and 24 weeks 6. Cognitive functioning measured using the Perceived Deficit Questionnaire (PDQ-5) at 12 and 24 weeks 7. Functional Impairment measured using the Work and Social Adjustment Scale (WSAS) (Question 4 from Productivity Cost Questionnaire (iPCQ) for absenteeism and Question 8 from iPCQ for presenteeism added) at 12 and 24 weeks 8. Health-related quality-of-life measured using the Short Form Questionnaire (SF-12) at 12 and 24 weeks 9. Cognitive dysfunction measured using the Cognitive Failure Questionnaire (CFQ) if a patient scores 3 or more on PDQ5 (patients receive an email to complete this questionnaire online via a secure password and patient ID number) at 12 and 24 weeks 10. Organ impairment and healthcare utilisation measured using patient records and the case report form (CRF) at 12 and 24 weeks 11. Cost-effectiveness of integrated care pathway (ICP) measured using patient records and the case report form (CRF) at 12 and 24 weeks 12. Process outcomes for different ICP components: whether pre-specified subgroups of patients, either grouped by clinical symptom cluster or imaging findings, benefit from either early investigation with COVERSCAN™, IMPs or rehabilitation, measured through the ICP components including CoverScan and The Living With COVID Recovery App 13. Blood investigations (e.g., genomic, proteomic, metabolomic/lipidomic, functional T cell and live virus neutralisation assays and endocrine analysis) measured using the research blood collected on study at baseline and 12 weeks Previous secondary outcome | — |
Countries
England, United Kingdom
Outcome results
None listed