Background: The COVID-19 pandemic has impacted millions of lives globally. While COVID-19 did not discriminate against developed or developing nations, it has been a significant challenge for third world countries like Honduras to have widespread availability of advanced therapies. The concept of early treatment was almost unheard of when early outpatient treatments utilizing repurposed drugs in Latin American countries began showing promising results. One such drug is fluvoxamine, which has shown tremendous potential in two major studies. As a direct result, fluvoxamine was added to the standard of care in a major medical center outpatient COVID-19 clinic.Methods: This is a prospective observational study performed at the Hospital Centro Médico Sampedrano (CEMESA) in San Pedro Sula, Cortes, Honduras in the COVID-19 outpatient clinic. All patients were at least 15 years of age who had presented with mild or moderate signs and symptoms of COVID-19, and who also had a documented positive SARS-CoV-2 antigen or Reverse Transcription Polymerase Chain Reaction (RT-PCR) were included in the study. These patients then were all prescribed fluvoxamine. The cohort of patients who decided to take fluvoxamine were compared for primary endpoints of mortality and hospitalization risk to the cohort who did not take fluvoxamine. Patients were then monitored for 30 days with the first follow up at 7 days and the second follow up at 10–14 days of symptom onset. Categorical variables were compared by Pearson Chi-square test. The Relative risk was calculated using regression models. Continuous variables were compared by t-test and Wilcoxon rank-sum tests.Results: Out of total 657 COVID-19 cases, 594 patients took fluvoxamine and 63 did not take fluvoxamine. A total of five patients (0.76 percent) died, with only one death occurring in the fluvoxamine group. Patients who received fluvoxamine had a significantly lower relative risk of mortality (RR 0.06, p 0.011, 95% CI 0.007–0.516). There was a lower relative risk of hospitalization in the patients who in the fluvoxamine group. (−10 vs. 30 hospitalizations, RR 0.49, p = 0.035, 95% CI 0.26–0.95). There was 73 percent reduction in relative risk of requiring oxygen in the fluvoxamine group (RR 0.27, p < 0.001, 95% CI 0.14–0.54 Mean lymphocytes count on the first follow-up visit was significantly higher in the fluvoxamine group (1.72 vs. 1.38, Δ 0.33, p 0.007, CI 0.09–0.58).Conclusion: The results of our study suggest that fluvoxamine lowers the relative risk of death, hospitalization, and oxygen requirement in COVID 19 patients.
Purpose: Our group demonstrated the safety, efficacy, and antiviral effect of intranasally administered Chlorpheniramine Maleate (CPM) for treating coronavirus disease 2019 (COVID-19). Since the nasal cavity is the portal of entry for COVID pathogens, sensory and upper respiratory symptoms (URS) (e.g., cough, ageusia, anosmia, nasal congestion, etc.) are significant symptoms in the course of the disease. Intranasal therapies could alleviate the disease-induced URS faster. This study evaluated the effectiveness and safety of intranasal CPM for treating mild to moderate COVID-19-induced URS in the outpatient setting. Methods: The two-part Accelerating COVID-19 Clinical Recovery in an Outpatient Setting (ACCROS) research study was conducted to collect evidence from a randomized, double-blinded placebo-controlled trial (ACCROS-I). Both parts enrolled patients with mild to moderate COVID-19 confirmed by reverse transcription-polymerase chain reaction. The primary endpoint in ACCROS-I was time to clinical recovery, defined as the change from baseline to day 7 in COVID-19 symptoms reported as the percent change (Δ%) in the daily symptoms score (DSS) and the severity of the disease symptoms using a visual analog scale (VAS), on a scale of 1-10 (10=worst symptoms). COVID-19 patients (n = 101) were recruited and assigned to either a 10-day CPM treatment (n=61) or placebo (PLB) (n=40) in addition to standard of care (SoC). Secondary endpoints included the incidence of hospitalization and the proportion of patients with URS on day 7. ACCROS-II data were collected from medical records of COVID-positive subjects using a standardized form. Cohorts of patients treated with CPM and SoC (CPM+Soc) were compared for the duration of general symptoms and URS. Patient information was collected as part of routine visits and telehealth consultations. Results ACCROS-I: There was a statistically significant difference in the rate of clinical recovery (P<0.05) in Δ%DSS (M -18.8±SEM 7.9%) and Δ%VAS (-8.6±5.1%), such that the CPM group reported fewer symptoms than PLB. The proportion of patients who reported sensory deficits and URS at day 7 was significantly lower (P<0.05) in CPM vs. PLB for ageusia (1.7% vs. 15.0%), cough (16.4% vs. 35.0%) and nasal congestion (8.1%vs.20%). None of the patients required hospitalization. ACCROS-II: There was a statistically significant reduction (P<0.05) in total days reporting URS for general symptoms of COVID-19 in CPM+SoC (5.1 ± 0.1) compared to SoC (11.0 ± 0.2). CPM+SoC users also showed fewer days with cough, anosmia, and ageusia. Persistent anosmia (over 29 days) was found in 3% of the patients on SoC, whereas no persistent anosmia was reported in the CPM+SoC cohort (X2 = 10.18; P<0.001). Conclusion: The result of this two-part study supports the conclusion that intranasal CPM is an antiviral agent that can be administered intranasally to treat COVID-19-induced symptoms effectively. Intranasal CPM accelerates clinical recovery and reduces URS in patients with mild to moderate COVID-19. This study's important implications include individuals returning to daily life faster, reducing community and individual economic burden, and decreasing healthcare utilization. Trial registration: ClinicalTrials.gov.; ID: NCT05449405 ACCROS-I retrospectively registered on 7/13/2022, NCT05520944 ACCROS-R retrospectively registered on 08/27/2022.
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