Randomised Evaluation of Covid-19 Therapy (RECOVERY)
Tahapan Penelitian : Initial
Sponsor:
Universitas Oxford, Inggris
Mitra Pelaksana:
Fakultas Kedokteran Universitas Indonesia-Jakarta, RS Martha Friska-Medan, RS Metropolitan Medical Center (MMC)-Jakarta dan Oxford University Clinical Research Unit Indonesia (a.k.a. EOCRU)-Jakarta
No Registry
INA-HOZ2FWH
Tanggal Input Registry : 04-03-2021
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 25-03-2021 |
| Outcome Primer | Provides reliable estimates of the effect of test drugs on mortality (all-cause mortality) at 28 days after randomization (with additional analysis of cause of death and occurrence of death at various time points after patient discharge from hospital . |
| Outcome Skunder | Tujuan sekunder: menilai efek obat-obat uji terhadap durasi perawatan di rumah sakit, dan antara pasien yang tidak menggunakan ventilasi mekanik invasif pada saat baseline, endpoint komposit berupa kematian atau kebutuhan ventilasi mekanik invasif atau extracorporeal membrane oxygenation (ECMO) Tujuan tersier: menilai efek obat-obat studi terhadap: • kebutuhan ventilasi dan durasinya • kebutuhan terapi pengganti renal (renal replacements therapy) • kasus baru aritmia kardiak mayor |
| Descriptive Information | |
| Judul Penelitian Popular | Randomised Evaluation of Covid-19 Therapy (RECOVERY) |
| Judul Penelitian Ilmiah | Randomised Evaluation of Covid-19 Therapy (RECOVERY) |
| Jenis Penelitian | Interventional |
| Intervensi | RECOVERY is an open-label, randomized trial in patients hospitalized with COVID-19. A factorial design is used so that subjects who meet the requirements and agree to take part in the research can be randomized/randomized into one of the main randomization groups, namely: (Primary Randomization part A of the protocol) • Routine care without additional medication • Colchicine 500 mg (oral or nasogastric tube) or intravenous 1x/day for 10 days or Main Randomization group part C: • Routine care without additional medication • Aspirin 150 mg (oral or nasogastric tube) or rectally 1x/day until the patient is discharged from hospital. |
| Jumlah Subyek Penelitian | 2000 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: (i) Dirawat di rumah sakit (ii) Mengalami penyakit terkait infeksi SARS-CoV-2 (dicurigai secara klinis atau dikonfirmasi laboratorium) Secara umum, infeksi SARS-CoV-2 harus dicurigai jika seorang pasien datang dengan: (a) Gejala khas/tipikal (misalnya penyakit menyerupai influenza dengan demam dan nyeri otot, atau penyakit saluran pernapasan dengan batuk dan sesak napas); dan (b) Gambaran X-ray toraks yang sesuai (konsolidasi atau bayangan ground-glass); dan (c) Penyebab lain/alternatif telah dinilai tidak memungkinkan atau dieksklusi (misalnya gagal jantung, influenza) Namun diagnosis tetap merupakan diagnosis klinis berdasarkan pendapat dokter yang merawat. (iii) Tidak ada riwayat medis yang menempatkan pasien pada risiko yang signifikan jika dia berpartisipasi dalam penelitian, berdasarkan pendapat dokter yang merawatExclusion Criteria: Participants may not be able to take part in the study if they experience the following conditions: (i) There are specific contra-indications for any of the treatment groups active drug or the patient must receive one of the active drugs from the treatment group so that the patient cannot be randomized. (ii) Unable to follow research directions/instructions or do not want to participate In some locations including Indonesia, only adults (> 18 years of age) will be recruited. |
| Administrative Information | |
| Nomor Persetujuan Etik | Surat Lolos Kaji Etik FKUI No. KET-1360/UN2.F1/ETIK/ PPM.00.02/2020 dated 16 November 2020 dan Persetujuan Amandemen Etik FKUI No. ND-1561/UN2.F1/ETIK/ PPM.00.02/2020 dated 21 Desember 2020 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | FKUI Ref No. 20-11-1405 |
| Contact Person | Dr. dr. Erni Juwita Nelwan, PhD, SpPD_KPTI, FACP, FINASIM |