ABSTRACT
Introduction: Human coronavirus disease 2019 (COVID-19) is an emerging respiratory disease that has become pandemic worldwide. The patients have a range of mild to severe symptoms, such as pneumonia, acute respiratory distress syndrome, arrhythmia, shock, and other organs involvement. Clinical and hematological evidence can serve as a prognostic factor to detect severe cases of COVID-19. Objectives: The present study aimed to evaluate hematological parameters related to the severity of the disease in COVID-19 patients in Mashhad, Eastern Iran. Patients and Methods: All the individuals with positive real-time reverse transcription-polymerase chain reaction test results and the patients with clinical symptoms whose computed tomography scan results were matched with the diagnosis of viral pneumonia were included in the study. The hematological examinations and complete blood count of the patients were performed by the healthcare personnel through collecting blood samples at the time of admission and discharge from the hospital. Results: In total, 189 COVID-19 patients were included in the study, 47.6% and 58.73% of whom were over 60 years old and male, respectively. Investigation of the hematological parameters revealed that the number of white blood cells, mean value of corpuscular volume, number of platelets, and lymph count had significantly increased at the time of discharge (P < 0.01). On the other hand, red blood cells, hemoglobin, hematocrit, mean corpuscular hemoglobin, mean corpuscular hemoglobin, and red cell distribution width values were significantly higher at the time of admission in comparison to discharge (P < 0.01). Furthermore, it was found that male gender had a significant relationship with the development of lymphopenia in the patients (P=0.021). Conclusion: It can be concluded that hematological parameters and inflammatory biomarkers in COVID-19 patients could potentially act as the independent factors and affect the prognosis of the disease.
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 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 SIZE: The calculated total sample size is 60 patients, with 30 patients in each group.