Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: study protocol for a randomized controlled trial.

ABSTRACT

OBJECTIVES: In this study, we will investigate the effect of hydroxychloroquine on the prevention of novel coronavirus disease (COVID-19) in cancer patients being treated. TRIAL DESIGN: This is a two-arm, parallel-group, triple-blind, phase 2-3 randomized controlled trial. PARTICIPANTS: All 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 COMPARATOR Patients 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 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. RANDOMIZATION Randomization 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 11. 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 SIZE The calculated total sample size is 60 patients, with 30 patients in each group.