COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN10665760

Amitava Banerjee

ami.banerjee@ucl.ac.uk

2022-05-30

Recruiting

RCT

Randomized

Cluster

Open label

multi-center

Long covid

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 post-menopausal 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 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 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

4

University College London

18

100

United Kingdom

Patients recovered from covid

N/A

4520

Fatigue measured using the Fatigue Assessment Scale at baseline;12 and 24 weeks

Phase 3

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