Abstract
ObjectivesIn this study, we will investigate the effect of hydroxychloroquine on the prevention of novel coronavirus disease (COVID-19) in cancer patients being treated.Trial designThis is a two-arm, parallel-group, triple-blind, phase 2–3 randomized controlled trial.ParticipantsAll patients over the age of 15 years from 5 types of cancer will be included in the study. Patients with acute lymphoid and myeloid leukemias in the first line treated with curative intent, patients with high-grade non-Hodgkin’s lymphoma treated with leukemia regimens, and patients with non-metastatic breast and colon cancer in the first line of treatment will enter the study.Intervention and comparatorPatients are randomly assigned to two groups: one being given hydroxychloroquine and the other is given placebo. During 2 months of treatment, the two groups will be treated with hydroxychloroquine every other day with a single 200-mg tablet (Amin® Pharmaceutical Company, Isfahan, Iran) or placebo (identical in terms of shape, color, and smell). Patients will be monitored for COVID-19 symptoms during follow-up period.If any COVID-19-related signs or symptoms occur, they will be examined, thoroughly, investigated with a high resolution computerize tomography (CT) scan of the lungs and nasopharyngeal swab assessed by RT-PCR for SARS-CoV-2 virus. This study will be performed in five centers affiliated to Mashhad University of Medical Sciences, Mashhad, Iran.Main outcomesThe primary end point of this study is to investigate the incidence of COVID-19 in patients being treated for their cancer and receiving prophylactic Hydroxychloroquine.RandomizationRandomization will be performed using random permuted blocks. By using online website (www.randomization.com), the randomization sequence will be produced by quadruple blocks. The allocation ratio in intervention and control groups is 1:1.Blinding (masking)Participants and caregivers do not know whether the patient is in the intervention or the control group. Those assessing the outcomes and data analyzer are also blinded to group assignment.Sample sizeThe calculated total sample size is 60 patients, with 30 patients in each group.
Highlights
Background and rationale {6a} The emergence of coronavirus disease 2019 (COVID-19) caused by a novel virus from the coronavirus family named SARS-CoV-2 has imposed enormous health and economic problems worldwide.On the last days of 2019, this disease was reported for the first time in Wuhan, capital of Hubei province, inChina, presented with pneumonia
Main outcomes: The primary end point of this study is to investigate the incidence of COVID-19 in patients being treated for their cancer and receiving prophylactic Hydroxychloroquine
We aimed to investigate the effect of the drug hydroxychloroquine on reducing the incidence of COVID-19 disease in cancer patients being treated for their cancer
Summary
Background and rationale {6a} The emergence of coronavirus disease 2019 (COVID-19) caused by a novel virus from the coronavirus family named SARS-CoV-2 has imposed enormous health and economic problems worldwide.On the last days of 2019, this disease was reported for the first time in Wuhan, capital of Hubei province, inChina, presented with pneumonia. Background and rationale {6a} The emergence of coronavirus disease 2019 (COVID-19) caused by a novel virus from the coronavirus family named SARS-CoV-2 has imposed enormous health and economic problems worldwide. Most of the studies have shown higher incidence and more severity of COVID-19 among cancerous patients [1,2,3,4,5,6,7]. COVID-19 imposes great concerns on the patients and their health care providers. Most studies have shown that COVID-19 disease is more severe in cancer patients than others, and the people with cancer have a higher risk of death from COVID-19 disease [6, 9,10,11,12,13,14,15,16]
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