ABSTRACT
This study was designed to evaluate the effects of colchicine in the improvement of clinical outcomes of hospitalized COVID-19 patients. This prospective, randomized, double-blind, placebo-controlled clinical trial was conducted on adult patients (>18 years) with severe COVID-19. The included patients were randomly (1:1) assigned to the colchicine (2 mg loading dose followed by 0.5 mg twice daily for 7 days) or placebo group. Both groups received remdesivir and interferon beta-1b. The primary outcome of the study was to receive clinical response as ordinal scale of 1 or 2. Secondary outcomes were hospital complications and 28-day mortality. Between February and May 2021, 110 patients were included and 106 of them were analyzed. Baseline clinical characteristics and demographics were not significantly different. According to the ordinal scale, 30 patients in the control group (58.8%) responded to treatment within 7 days, while 35 patients (63.6%) in the colchicine group showed the same response (p = 0.61, odds ratio (OR) = 1.23, 95% CI [0.560-2.68]). On the 14th day, 87.3% of the colchicine group (n = 48) and 82.4% of the control group (n = 42) responded (p = 0.48, OR = 1.47, 95% CI [0.50.3-4.29]. In addition, 28-day mortality, intensive care unit admission, and hospital duration were not different between the groups (p = 0.99, 0.59, 0.06). Diarrhea and nausea were the major side effects dominant in the colchicine group. Colchicine showed no beneficial effects on clinical improvement and hospital complications in patients with COVID-19. Moreover, in case of prescription, the safety concerns of colchicine, specially gastrointestinal side effects, should be taken into account.
Subject(s)
COVID-19 , Adult , Humans , Colchicine/therapeutic use , SARS-CoV-2 , Prospective Studies , Hospitalization , Double-Blind Method , Treatment OutcomeABSTRACT
PURPOSE: Coronavirus disease 2019 (COVID-19) has been associated with a high rate of mortality and morbidity. While a high portion of COVID-19 patients have mild symptoms, a limited number of clinical trials have evaluated the clinical course of this large group of patients. This study was designed to investigate the demographics and clinical characteristics and comorbidity of nonhospitalized COVID-19 patients. METHODS: This prospective, observational cohort study was performed on nonhospitalized adult patients (≥18 years) with COVID-19. Pharmacotherapy service was responsible for patients' assessment for up to 1 month. Demographic characteristics, the onset of symptoms, severity, duration, laboratory data, and hospitalization rate were evaluated by a pharmacist-based monitoring program. RESULTS: From 323 patients who had been referred to the emergency department, 105 individuals were recruited between April 26 and August 2, 2020. Most of the patients were female (66.7%) with a mean age of 39.39 years (SD: ± 15.82). The mean time of the symptom onset was 5.6 days (SD: ±1.79). The majority of patients suffered from fatigue (78.1%), sore throat (67.6%), cough (60%), and myalgia (55.2%). C-reactive protein, white blood cell, lymphocyte, neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and hemoglobin levels were recovered significantly during the first two weeks (P < 0.001). Hydroxychloroquine, naproxen, diphenhydramine, azithromycin, and vitamin D3 were the most common medications administered (98%, 96%, 94%, 68%, and 57%, respectively). Forty patients were not symptom-free after the one-month follow-up, and 8 patients (7.6%) were required to revisit without the need for hospitalization. Anosmia (18.1%) and fatigue (17.1%) were the most common persisted symptoms. There were no significant differences between symptom-free and symptomatic patients. CONCLUSION: Mild COVID-19 patients had a wide variety of symptoms and could be symptomatic even one month after the onset of symptoms. The pharmacist-based monitoring system can contribute beneficially to patients through the evaluation of symptoms, reduction of unnecessary visits, and provision of updated information to patients concerning the status of their illness.
ABSTRACT
The aim of this study was to evaluate the usage of mometasone furoate nasal spray in the recovery of patients with severe microsmia or anosmia induced by COVID-19. This was a prospective clinical trial on non-hospitalized adult patients with COVID-19 (>18 years) who had severe microsmia or anosmia within two weeks. The subjects were randomly assigned to the mometasone furoate group (100 mcg twice daily) or sodium chloride group (0.9%); both groups also received olfactory training for 4 weeks. The primary outcome was the improvement of the olfactory score at the end of the study. Visual analog scale (VAS) and the University of Pennsylvania Smell Identification Test (UPSIT) were used to assess primary outcome. A total of 80 patients were recruited, 77 of them completed the study and were analyzed. There was no statistically significant difference in terms of demographics and baseline clinical characteristics. The olfactory scores (based on VAS) at weekly intervals showed a significant difference between the two groups (P:0.318, <0.001, <0.001, <0.001, respectively). The analyses also showed significant within-group differences from baseline. Nevertheless, the changes were not significant between the two groups (P: 0.444, 0.402, 0.267, 0.329). There was no significant difference between the two groups in terms of the UPSIT results (p > 0.239). However, a significant between-group difference was noted in the severity of loss of smell (P < 0.001). Compared to olfactory training, mometasone furoate nasal spray combination with olfactory training showed a higher improvement in severe chronic anosmia by COVID-19.