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2.
Trials ; 23(1): 273, 2022 Apr 08.
Article in English | MEDLINE | ID: covidwho-2098437

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) has a heterogeneous outcome in individuals from remaining asymptomatic to death. In a majority of cases, mild symptoms are present that do not require hospitalization and can be successfully treated in the outpatient setting, though symptoms may persist for a long duration. We hypothesize that drugs suitable for decentralized study in outpatients will have efficacy among infected outpatients METHODS: The TREAT NOW platform is designed to accommodate testing multiple agents with the ability to incorporate new agents in the future. TREAT NOW is an adaptive, blinded, multi-center, placebo-controlled superiority randomized clinical trial which started with two active therapies (hydroxychloroquine and lopinavir/ritonavir) and placebo, with the hydroxychloroquine arm dropped shortly after enrollment began due to external evidence. Each arm has a target enrollment of 300 participants who will be randomly assigned in an equal allocation to receive either an active therapy or placebo twice daily for 14 days with daily electronic surveys collected over days 1 through 16 and on day 29 to evaluate symptoms and a modified COVID-19 ordinal outcome scale. Participants are enrolled remotely by telephone and consented with a digital interface, study drug is overnight mailed to study participants, and data collection occurs electronically without in-person interactions. DISCUSSION: If effective treatments for COVID-19 can be identified for individuals in the outpatient setting before they advance to severe disease, it will prevent progression to more severe disease, reduce the need for hospitalization, and shorten the duration of symptoms. The novel decentralized, "no touch" approach used by the TREAT NOW platform has distinction advantages over traditional in-person trials to reach broader populations and perform study procedures in a pragmatic yet rigorous manner. TRIAL REGISTRATION: ClinicalTrials.gov NCT04372628. Registered on April 30, 2020. First posted on May 4, 2020.


Subject(s)
COVID-19 , Antiviral Agents/adverse effects , COVID-19/drug therapy , Hospitalization , Humans , Hydroxychloroquine/adverse effects , Outpatients , Randomized Controlled Trials as Topic , SARS-CoV-2 , Treatment Outcome
3.
PLoS One ; 17(8): e0272034, 2022.
Article in English | MEDLINE | ID: covidwho-2079709

ABSTRACT

RATIONALE: Inhaled antimicrobials enable high local concentrations where needed and, compared to orally administration, greatly reduce the potential for systemic side effects. In SARS-CoV-2 infections, hydroxychloroquine sulphate (HCQ) administered as dry powder via inhalation could be safer than oral HCQ allowing higher and therefore more effective pulmonary concentrations without dose limiting toxic effects. OBJECTIVES: To assess the local tolerability, safety and pharmacokinetic parameters of HCQ inhalations in single ascending doses of 5, 10 and 20 mg using the Cyclops dry powder inhaler. METHODS: Twelve healthy volunteers were included in the study. Local tolerability and safety were assessed by pulmonary function tests, electrocardiogram and recording adverse events. To estimate systemic exposure, serum samples were collected before and 0.5, 2 and 3.5 h after inhalation. RESULTS AND DISCUSSION: Dry powder HCQ inhalations were well tolerated by the participants, except for transient bitter taste in all participants and minor coughing irritation. There was no significant change in QTc-interval or drop in FEV1 post inhalation. The serum HCQ concentration remained below 10 µg/L in all samples. CONCLUSION: Single doses of inhaled dry powder HCQ up to 20 mg are safe and well tolerated. Our data support that further studies with inhaled HCQ dry powder to evaluate pulmonary pharmacokinetics and efficacy are warranted.


Subject(s)
COVID-19 , Hydroxychloroquine , Administration, Inhalation , COVID-19/drug therapy , Dry Powder Inhalers , Healthy Volunteers , Humans , Hydroxychloroquine/adverse effects , Powders , SARS-CoV-2
4.
Trials ; 23(1): 881, 2022 Oct 18.
Article in English | MEDLINE | ID: covidwho-2079536

ABSTRACT

AIM: To inform the oversight of future clinical trials during a pandemic, we summarise the experiences of the Data Monitoring Committee (DMC) for the Randomised Evaluation of COVID therapy trial (RECOVERY), a large-scale randomised adaptive platform clinical trial of treatments for hospitalised patients with COVID-19. METHODS AND FINDINGS: During the first 24 months of the trial (March 2020 to February 2022), the DMC oversaw accumulating data for 14 treatments in adults (plus 10 in children) involving > 45,000 randomised patients. Five trial aspects key for the DMC in performing its role were: a large committee of members, including some with extensive DMC experience and others who had broad clinical expertise; clear strategic planning, communication, and responsiveness by the trial principal investigators; data collection and analysis systems able to cope with phases of very rapid recruitment and link to electronic health records; an ability to work constructively with regulators (and other DMCs) to address emerging concerns without the need to release unblinded mortality results; and the use of videoconferencing systems that enabled national and international members to meet at short notice and from home during the pandemic when physical meetings were impossible. Challenges included that the first four treatments introduced were effectively 'competing' for patients (increasing pressure to make rapid decisions on each one); balancing the global health imperative to report on findings with the need to maintain confidentiality until the results were sufficiently certain to appropriately inform treatment decisions; and reliably assessing safety, especially for newer agents introduced after the initial wave and in the small numbers of pregnant women and children included. We present a series of case vignettes to illustrate some of the issues and the DMC decision-making related to hydroxychloroquine, dexamethasone, casirivimab + imdevimab, and tocilizumab. CONCLUSIONS: RECOVERY's streamlined adaptive platform design, linked to hospital-level and population-level health data, enabled the rapid and reliable assessment of multiple treatments for hospitalised patients with COVID-19. The later introduction of factorial assessments increased the trial's efficiency, without compromising the DMC's ability to assess safety and efficacy. Requests for the release of unblinded primary outcome data to regulators at points when data were not mature required significant efforts in communication with the regulators by the DMC to avoid inappropriate early trial termination.


Subject(s)
COVID-19 , Adult , Child , Humans , Female , Pregnancy , Hydroxychloroquine/adverse effects , SARS-CoV-2 , Clinical Trials Data Monitoring Committees , Dexamethasone , Treatment Outcome
5.
Ann Afr Med ; 21(3): 301-304, 2022.
Article in English | MEDLINE | ID: covidwho-2055682

ABSTRACT

Irreversible visual loss due to retinal toxicity is one of the side effects of hydroxychloroquine (HCQ) therapy. The recent outbreak of the novel coronavirus-19 (COVID 19) has seen HCQ proposed as a possible treatment and prophylactic drug, leading to its increased use. Many are unaware of its ocular side effects. We describe a case of HCQ-induced retinopathy in a 46-year-old female who was referred by a rheumatologist for routine eye review.


Résumé La perte de vision irréversible secondaire à la toxicité rétinienne est l'un des effets indésirables du traitement à l'hydroxychloroquine (HCQ). Nous décrivons un cas d'une patiente âgée de 46 ans, présentant une rétinopathie secondaire au traitement à l'HCQ référée par un Rhumathologue pour un examen ophtalmique. Mots-clés: Hydroxychloroquine, rétine toxicité rétinienne, rétinopathie.


Subject(s)
Antirheumatic Agents , COVID-19 , Retinal Diseases , Antirheumatic Agents/adverse effects , COVID-19/drug therapy , Female , Humans , Hydroxychloroquine/adverse effects , Kenya , Middle Aged , Retina , Retinal Diseases/chemically induced , Retinal Diseases/epidemiology , Tomography, Optical Coherence
6.
PLoS One ; 17(9): e0273526, 2022.
Article in English | MEDLINE | ID: covidwho-2054327

ABSTRACT

BACKGROUND: Results from observational studies and randomized clinical trials (RCTs) have led to the consensus that hydroxychloroquine (HCQ) and chloroquine (CQ) are not effective for COVID-19 prevention or treatment. Pooling individual participant data, including unanalyzed data from trials terminated early, enables more detailed investigation of the efficacy and safety of HCQ/CQ among subgroups of hospitalized patients. METHODS: We searched ClinicalTrials.gov in May and June 2020 for US-based RCTs evaluating HCQ/CQ in hospitalized COVID-19 patients in which the outcomes defined in this study were recorded or could be extrapolated. The primary outcome was a 7-point ordinal scale measured between day 28 and 35 post enrollment; comparisons used proportional odds ratios. Harmonized de-identified data were collected via a common template spreadsheet sent to each principal investigator. The data were analyzed by fitting a prespecified Bayesian ordinal regression model and standardizing the resulting predictions. RESULTS: Eight of 19 trials met eligibility criteria and agreed to participate. Patient-level data were available from 770 participants (412 HCQ/CQ vs 358 control). Baseline characteristics were similar between groups. We did not find evidence of a difference in COVID-19 ordinal scores between days 28 and 35 post-enrollment in the pooled patient population (odds ratio, 0.97; 95% credible interval, 0.76-1.24; higher favors HCQ/CQ), and found no convincing evidence of meaningful treatment effect heterogeneity among prespecified subgroups. Adverse event and serious adverse event rates were numerically higher with HCQ/CQ vs control (0.39 vs 0.29 and 0.13 vs 0.09 per patient, respectively). CONCLUSIONS: The findings of this individual participant data meta-analysis reinforce those of individual RCTs that HCQ/CQ is not efficacious for treatment of COVID-19 in hospitalized patients.


Subject(s)
COVID-19 , Hydroxychloroquine , COVID-19/drug therapy , Chloroquine/adverse effects , Data Analysis , Humans , Hydroxychloroquine/adverse effects
7.
Curr Heart Fail Rep ; 19(6): 458-466, 2022 12.
Article in English | MEDLINE | ID: covidwho-2048548

ABSTRACT

PURPOSE OF REVIEW: The coronavirus disease 2019 (COVID-19) pandemic has popularized the usage of hydroxychloroquine and chloroquine (HCQ/CQ) as treatments for COVID-19. Previously used as anti-malarial and now commonly used in rheumatologic conditions, preliminary in vitro studies have demonstrated these medications also have anti-viral properties. Retinopathy and neuromyopathy are well recognized complications of using these treatments; however, cardiotoxicity is under-recognized. This review will discuss the implications and cardiotoxicity of HCQ/CQ, their mechanisms of action, and their utility in COVID-19. RECENT FINDINGS: Early clinical trials demonstrated a modest benefit of HCQ in COVID-19, causing a push for the usage of it. However, further large multi-center randomized control centers, demonstrated no benefit, and even a trend towards worse outcomes. The predominant cardiac complication observed with HCQ in COVID-19 was cardiac arrhythmias and prolonging of the QT interval. However, with chronic usage of HCQ/CQ, the development of heart failure (HF) and cardiomyopathy (CM) can occur. Although, most adverse cardiac events related to HCQ/CQ usage in COVID-19 were secondary to conduction disorders given the short duration of treatment, HCQ/CQ can cause CM and HF, with chronic usage. Given the insufficient evidence, HCQ/CQ usage in COVID-19 is not routinely recommended, especially with novel therapies now being developed and used. Additionally, usage of HCQ/CQ should prompt initial cardiac evaluation with ECG, and yearly monitoring, with consideration for advanced imaging if clinically warranted. The diagnosis of HCQ/CQ cardiomyopathy is important, as prompt cessation can allow for recovery when these changes are still reversible.


Subject(s)
COVID-19 , Heart Failure , Humans , Hydroxychloroquine/adverse effects , Pandemics , COVID-19/drug therapy , SARS-CoV-2 , Cardiotoxicity/etiology , Heart Failure/drug therapy , Chloroquine/adverse effects
9.
Eur J Epidemiol ; 37(8): 789-796, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-2035117

ABSTRACT

BACKGROUND: Recruitment into randomized trials of hydroxychloroquine (HCQ) for prevention of COVID-19 has been adversely affected by a widespread conviction that HCQ is not effective for prevention. In the absence of an updated systematic review, we conducted a meta-analysis of randomized trials that study the effectiveness of HCQ to prevent COVID-19. METHODS: A search of PubMed, medRxiv, and clinicaltrials.gov combined with expert consultation found 11 completed randomized trials: 7 pre-exposure prophylaxis trials and 4 post-exposure prophylaxis trials. We obtained or calculated the risk ratio of COVID-19 diagnosis for assignment to HCQ versus no HCQ (either placebo or usual care) for each trial, and then pooled the risk ratio estimates. RESULTS: The pooled risk ratio estimate of the pre-exposure prophylaxis trials was 0.72 (95% CI: 0.58-0.90) when using either a fixed effect or a standard random effects approach, and 0.72 (95% CI: 0.55-0.95) when using a conservative modification of the Hartung-Knapp random effects approach. The corresponding estimates for the post-exposure prophylaxis trials were 0.91 (95% CI: 0.72-1.16) and 0.91 (95% CI: 0.62-1.35). All trials found a similar rate of serious adverse effects in the HCQ and no HCQ groups. DISCUSSION: A benefit of HCQ as prophylaxis for COVID-19 cannot be ruled out based on the available evidence from randomized trials. However, the "not statistically significant" findings from early prophylaxis trials were widely interpreted as definite evidence of lack of effectiveness of HCQ. This interpretation disrupted the timely completion of the remaining trials and thus the generation of precise estimates for pandemic management before the development of vaccines.


Subject(s)
COVID-19 , Hydroxychloroquine , COVID-19/drug therapy , COVID-19/prevention & control , COVID-19 Testing , Humans , Hydroxychloroquine/adverse effects , Hydroxychloroquine/therapeutic use , Randomized Controlled Trials as Topic , SARS-CoV-2
10.
Otol Neurotol ; 43(9): e944-e950, 2022 10 01.
Article in English | MEDLINE | ID: covidwho-1992399

ABSTRACT

BACKGROUND AND OBJECTIVES: Concerns about ototoxic and vestibulotoxic effects have been raised with the use of antiviruses in the treatment of COVID-19. This study aimed to determine the effect of hydroxychloroquine (HCQ) and examine the auditory system and its associated auditory and vestibular symptoms in patients with COVID-19. STUDY DESIGN: Prospective study. PATIENTS: Thirty patients with a history of HCQ (HCQ+) and 30 patients without drug use (HCQ-), and 30 healthy adults as the control group participated. MAIN OUTCOME MEASURES: Audiological assessments and evaluation of audio-vestibular symptoms. Evaluations were also repeated 1 month later. RESULTS: Both HCQ+ and HCQ- groups showed poor pure-tone audiometry (PTA) thresholds and decreased transient evoked otoacoustic emission amplitudes at high frequencies in comparison to the healthy group. Despite the lack of significant differences in PTA between the two groups of patients, the differences in transient evoked otoacoustic emission amplitudes were significant. PTA thresholds and otoacoustic emission showed improvement after 1 month. Dizziness was the most common symptom that was reduced after 1 month. CONCLUSION: Slight hearing loss was seen in patients with COVID-19 with or without HCQ. Also, hearing thresholds in the HCQ+ group did not show a significant difference compared with the HCQ- group. Nevertheless, it seems that more damage is done to the hair cells of patients with HCQ intake than in other patients. Hence, the ototoxicity effect of high doses of HCQ use in the COVID-19 patients should be considered. A relative improvement in the hearing was seen over time in both patient groups.


Subject(s)
COVID-19 , Hearing Loss, High-Frequency , Adult , Audiometry, Pure-Tone , Auditory Threshold , COVID-19/drug therapy , Humans , Hydroxychloroquine/adverse effects , Otoacoustic Emissions, Spontaneous/physiology , Prospective Studies
11.
Ann Pharm Fr ; 80(4): 531-542, 2022 Jul.
Article in French | MEDLINE | ID: covidwho-1977718

ABSTRACT

OBJECTIVES: The aim of the study is to provide an overview of Drug-drug Interactions (DDIs) and adverse effects caused by drugs used in SARS-CoV-2 infection during the first epidemic wave. METHODS: We retrospectively analyzed patients treated by drugs used in SARS-CoV-2 infection (Azithromycin, Hydroxychloroquine and/or Lopinavir/ritonavir) between 15th March 2020 to 17th April 2020. A review of adverse events and DDI-risky drug association on medical record was conducted for each patient. Each adverse events was analyzed by the Centre régional de pharmacovigilance (CRPV) to assess causality of drugs used in SARS-CoV-2 infection. RESULTS: A total of 312 precriptions were analyzed during the period, of which 110 prescriptions had 157 drug association at risk of DDIs; 26 adverse events were reported. Causality assessment by CRPV concluded that 10 (35,7 %) adverse effects were possibly related to SARS-CoV-2 drugs with only 2 (7,1 %) related to DDIs. CONCLUSIONS: Despite risk of adverse drug reactions and DDIs related to drugs used in SARS-CoV-2 infection, few iatrogenics diseases were found.


Subject(s)
COVID-19 , Antiviral Agents/adverse effects , COVID-19/drug therapy , Drug Interactions , Humans , Hydroxychloroquine/adverse effects , Retrospective Studies , Ritonavir/adverse effects , SARS-CoV-2
12.
Cad Saude Publica ; 38(7): e00001022, 2022.
Article in English | MEDLINE | ID: covidwho-1963142

ABSTRACT

Off-label use of azithromycin, hydroxychloroquine, and ivermectin (the "COVID kit") has been suggested for COVID-19 treatment in Brazil without clinical or scientific evidence of efficacy. These drugs have known adverse drug reactions (ADR). This study aimed to analyze if the sales of drugs in the "COVID kit" are correlated to the reported number of ADR after the COVID-19 pandemic began. Data was obtained from the Brazilian Health Regulatory Agency (Anvisa) website on reported sales and ADRs for azithromycin, hydroxychloroquine, and ivermectin for all Brazilian states. The period from March 2019 to February 2020 (before the pandemic) was compared to that from March 2020 to February 2021 (during the pandemic). Trend adjustment was performed for time series data and cross-correlation analysis to investigate correlation between sales and ADR within the same month (lag 0) and in the following months (lag 1 and lag 2). Spearman's correlation coefficient was used to assess the magnitude of the correlations. After the pandemic onset, sales of all investigated drugs increased significantly (69.75% for azithromycin, 10,856,481.39% for hydroxychloroquine, and 12,291,129.32% for ivermectin). ADR levels of all medications but azithromycin were zero before the pandemic, but increased after its onset. Cross-correlation analysis was significant in lag 1 for all drugs nationwide. Spearman's correlation was moderate for azithromycin and hydroxychloroquine but absent for ivermectin. Data must be interpreted cautiously since no active search for ADR was performed. Our results show that the increased and indiscriminate use of "COVID kit" during the pandemic correlates to an increased occurrence of ADRs.


Subject(s)
COVID-19 , Coronavirus Infections , Drug-Related Side Effects and Adverse Reactions , Pneumonia, Viral , Azithromycin/adverse effects , Brazil/epidemiology , COVID-19/drug therapy , Coronavirus Infections/drug therapy , Coronavirus Infections/epidemiology , Drug-Related Side Effects and Adverse Reactions/epidemiology , Humans , Hydroxychloroquine/adverse effects , Ivermectin/adverse effects , Pandemics , Pneumonia, Viral/drug therapy , Pneumonia, Viral/epidemiology
13.
Orphanet J Rare Dis ; 17(1): 289, 2022 07 23.
Article in English | MEDLINE | ID: covidwho-1962861

ABSTRACT

BACKGROUND: No results of controlled trials are available for any of the few treatments offered to children with interstitial lung diseases (chILD). We evaluated hydroxychloroquine (HCQ) in a phase 2, prospective, multicentre, 1:1-randomized, double-blind, placebo-controlled, parallel-group/crossover trial. HCQ (START arm) or placebo were given for 4 weeks. Then all subjects received HCQ for another 4 weeks. In the STOP arm subjects already taking HCQ were randomized to 12 weeks of HCQ or placebo (= withdrawal of HCQ). Then all subjects stopped treatment and were observed for another 12 weeks. RESULTS: 26 subjects were included in the START arm, 9 in the STOP arm, of these four subjects participated in both arms. The primary endpoint, presence or absence of a response to treatment, assessed as oxygenation (calculated from a change in transcutaneous O2-saturation of ≥ 5%, respiratory rate ≥ 20% or level of respiratory support), did not differ between placebo and HCQ groups. Secondary endpoints including change of O2-saturation ≥ 3%, health related quality of life, pulmonary function and 6-min-walk-test distance, were not different between groups. Finally combining all placebo and all HCQ treatment periods did not identify significant treatment effects. Overall effect sizes were small. HCQ was well tolerated, adverse events were not different between placebo and HCQ. CONCLUSIONS: Acknowledging important shortcomings of the study, including a small study population, the treatment duration, lack of outcomes like lung function testing below age of 6 years, the small effect size of HCQ treatment observed requires careful reassessments of prescriptions in everyday practice (EudraCT-Nr.: 2013-003714-40, www.clinicaltrialsregister.eu , registered 02.07.2013). Registration The study was registered on 2 July 2013 (Eudra-CT Number: 2013-003714-40), whereas the approval by BfArM was received 24.11.2014, followed by the approval by the lead EC of the University Hospital Munich on 20.01.2015. At clinicaltrials.gov the trial was additionally registered on November 8, 2015 (NCT02615938).


Subject(s)
COVID-19 , Lung Diseases, Interstitial , Child , Double-Blind Method , Humans , Hydroxychloroquine/adverse effects , Hydroxychloroquine/therapeutic use , Lung Diseases, Interstitial/drug therapy , Prospective Studies , Quality of Life , SARS-CoV-2 , Treatment Outcome
16.
Ann Afr Med ; 21(2): 113-117, 2022.
Article in English | MEDLINE | ID: covidwho-1954253

ABSTRACT

Background: Coronavirus disease-2019 (COVID-19) pandemic has engulfed the whole world with millions getting infected and losing their lives. Health care professionals (HCPs) who are in the front line of fighting with COVID-19 are particularly vulnerable and it is crucial to protect them from COVID-19. In this regard, the Indian Council of Medical Research (ICMR) has recommended hydroxychloroquine (HCQS) chemoprophylaxis in HCPs. However, considering the lack of sufficient evidence the HCP are in a dilemma about this aspect. Moreover, there is a paucity of data on use of HCQS as a chemoprophylaxis among Indian HCP. Hence, this study was carried out to study the extent of use and also the perception of Indian HCP toward use of HCQS as a chemoprophylaxis for COVID-19. Materials and Methods: This was a cross-sectional study done on 205 HCPs working across India. The responses were collected electronically using a prevalidated semi-structured questionnaire. Results: 62.9% (129/205) respondents reported having taken HCQS chemo-prophylaxis for COVID-19 while 34.7% (76/205) did not take it. Among HCP, who did not take the prophylaxis, the main reasons cited were concern about adverse effects (61.5%) and lack of robust evidence (24%). Only 14% of respondents felt that there was sufficient evidence to justify use of HCQS for prophylaxis while an overwhelming majority (86%) felt otherwise or were uncertain. Conclusion: The majority of participants felt that despite a lack of proven efficacy, ICMR guidelines on HCQS prophylaxis in COVID-19 are justified considering the pandemic situation. Our study also found that HCQS is well tolerated by participants and there was no reported serious adverse effect and cardiac-related side effects among them.


Résumé Contexte: La pandémie de maladie à coronavirus-2019 (COVID-19) a englouti le monde entier avec des millions de personnes infectées et perdant leur des vies. Les professionnels de la santé (HCP) qui sont en première ligne dans la lutte contre le COVID-19 sont particulièrement vulnérables et il est essentiel de les protéger du COVID-19. À cet égard, le Conseil indien de la recherche médicale (ICMR) a recommandé l'hydroxychloroquine (HCQS) chimioprophylaxie chez les professionnels de la santé. Cependant, compte tenu du manque de preuves suffisantes, le professionnel de la santé est confronté à un dilemme à propos de cet aspect. En outre, il y a peu de données sur l'utilisation du HCQS comme chimioprophylaxie parmi les professionnels de la santé indiens. Par conséquent, cette étude a été menée pour étudier l'étendue de l'utilisation et aussi la perception des professionnels de la santé indiens à l'égard de l'utilisation du HCQS comme chimioprophylaxie pour le COVID-19. Matériel et Méthodes: c'était un étude transversale réalisée sur 205 professionnels de la santé travaillant en Inde. Les réponses ont été recueillies par voie électronique à l'aide d'un système semi-structuré prévalidé questionnaire. Résultats: 62,9% (129/205) des répondants ont déclaré avoir suivi une chimioprophylaxie HCQS pour le COVID-19, tandis que 34,7% (76/205) ne l'a pas pris. Parmi les professionnels de la santé qui n'ont pas pris de prophylaxie, les principales raisons invoquées étaient la préoccupation concernant les effets indésirables (61,5%) et le manque de preuves solides (24%). Seulement 14% des répondants estimaient qu'il y avait des preuves suffisantes pour justifier l'utilisation du HCQS à des fins prophylactiques alors qu'un une écrasante majorité (86%) pensait le contraire ou était incertaine. Conclusion: La majorité des participants ont estimé que malgré un manque de efficacité, les lignes directrices de l'ICMR sur la prophylaxie du HCQS dans le COVID-19 sont justifiées compte tenu de la situation pandémique. Notre étude a également révélé que Le HCQS est bien toléré par les participants et aucun effet indésirable grave ni effet secondaire cardiaque n'a été signalé parmi eux. Mots-clés: Chimioprophylaxie, COVID-19, hydroxychloroquine, Conseil indien de la recherche médicale.


Subject(s)
COVID-19 , Coronavirus Infections , Pneumonia, Viral , COVID-19/drug therapy , COVID-19/prevention & control , Coronavirus Infections/drug therapy , Coronavirus Infections/epidemiology , Coronavirus Infections/prevention & control , Cross-Sectional Studies , Health Personnel , Humans , Hydroxychloroquine/adverse effects , Pneumonia, Viral/drug therapy , Pneumonia, Viral/epidemiology , Pneumonia, Viral/prevention & control , Surveys and Questionnaires
17.
Int J Clin Pharm ; 44(5): 1179-1187, 2022 Oct.
Article in English | MEDLINE | ID: covidwho-1942479

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) is a global pandemic. Hydroxychloroquine (HCQ)-associated cardiovascular adverse events (CVAEs) have been increasingly reported. AIM: This study aimed to present an observational, retrospective, and comprehensive pharmacovigilance analysis of CVAE associated with HCQ in patients with and without COVID-19 using the US Food and Drug Administration Adverse Events Reporting System (FAERS) data from January 2020 to December 2020. METHOD: We identified 3302 adverse event reports from the FAERS database in the year 2020 and divided them into COVID-19 and non-COVID-19 groups, respectively. Then we analyzed whether there were differences in CVAEs between the two groups. RESULTS: We found that CVAE was higher in cases with COVID-19 compared to those without COVID-19, odds ratio (OR) of 1.26 and a 95% confidence interval (95% CI) of 1.02-1.54. Cases with COVID-19 treated with HCQ exhibited relatively higher proportions of torsade de points (TdP) and QT prolongation (OR 3.10, 95% CI 2.24-4.30), shock-associated TdP (OR 2.93, 95% CI 2.13-4.04), cardiac arrhythmias (OR 2.07, 95% CI 1.60-2.69), cardiac arrhythmia terms (including bradyarrhythmias and tachyarrhythmias) (OR 2.15, 95% CI 1.65-2.80), bradyarrhythmias (including conduction defects and disorders of sinus node function) (OR 2.56, 95% CI 1.86-3.54), and conduction defects (OR 2.56, 95% CI 1.86-3.54). CONCLUSION: Our retrospective observational analysis suggested that the proportion of CVAE associated with HCQ, especially TdP and QT prolongation, was higher in patients with COVID-19. Understanding the effects of COVID-19 on the cardiovascular system is essential to providing comprehensive medical care to patients receiving HCQ treatment.


Subject(s)
COVID-19 , Cardiovascular System , Long QT Syndrome , Humans , Hydroxychloroquine/adverse effects , COVID-19/drug therapy , COVID-19/epidemiology , Pharmacovigilance , Retrospective Studies , Bradycardia/chemically induced , Long QT Syndrome/chemically induced , Long QT Syndrome/epidemiology , Arrhythmias, Cardiac/chemically induced , Arrhythmias, Cardiac/epidemiology , Arrhythmias, Cardiac/drug therapy , Cardiac Conduction System Disease/chemically induced , Cardiac Conduction System Disease/drug therapy , DNA-Binding Proteins
18.
Expert Rev Anti Infect Ther ; 20(10): 1341-1350, 2022 10.
Article in English | MEDLINE | ID: covidwho-1915427

ABSTRACT

BACKGROUND: To investigate the efficacy and safety of ivermectin compared to hydroxychloroquine and placebo in hospitalized moderate to severe COVID-19 patients. RESEARCH DESIGN AND METHODS: The study was an adaptive, randomized, double-blinded, controlled, single-center trial. The study was a series of 3-arm comparisons between two different investigational therapeutic agents (ivermectin and hydroxychloroquine) and a placebo. There was interim monitoring to allow early stopping for futility, efficacy, or safety. RESULTS: Ivermectin decreased survival time from 29 to 18.3 days (HR, 9.8, 95%CI, 3.7-26.2), while it did not shorten the recovery time (HR, 1.02, 95%CI, 0.69-1.5). Subgroup analysis showed an association between ivermectin-related mortality and baseline oxygen saturation level. Moreover, stratified groups showed higher risk among patients on high flow O2. Hydroxychloroquine delayed recovery from 10.1 to 12.5 days (HR, 0.62, 95%CI, 0.4-0.95) and non-significantly decreased survival time from 29 to 26.8 days (HR, 1.47, 95%CI, 0.73-2.9). However, 3 months mortality rates were increased with hydroxychloroquine (RR, 2.05, 95%CI, 1.33-3.16). Neither ivermectin nor hydroxychloroquine increased adverse events and demonstrated safety profile compared to placebo. CONCLUSIONS: The study recommends against using either ivermectin or hydroxychloroquine for treatment of COVID-19 in hospitalized patients with any degree of severity. Clinical trial registration: www.clinicaltrials.gov identifier is: NCT04746365.


Subject(s)
Antiparasitic Agents , COVID-19 , Ivermectin , COVID-19/drug therapy , Double-Blind Method , Humans , Hydroxychloroquine/adverse effects , Ivermectin/adverse effects , SARS-CoV-2 , Time Factors , Treatment Outcome
19.
J Clin Apher ; 37(5): 516-521, 2022 Oct.
Article in English | MEDLINE | ID: covidwho-1913819

ABSTRACT

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are life-threatening mucocutaneous reactions characterized by necrosis and detachment of the epidermis. Drugs and bacterial or viral infections are the most common causes of SJS/TEN. Although cases of SJS/TEN have been reported after hydroxychloroquine, vaccine (mRNA [Biontech], and inactivated vaccine [Sinovac]) administration and during the clinical course of active Coronavirus disease 2019 (COVID-19), limited data is indicating the COVID-19 disease as a triggering factor. Also, there are no pediatric cases of SJS/TEN associated with COVID-19 in the literature. Herein we reported two pediatric cases with a diagnosis of TEN related to COVID-19. Therapeutic plasma exchange therapy was applied to both of our patients. Although there are a few adult cases in the literature, our article is the first pediatric case report about patients diagnosed with TEN related to COVID-19 and successfully treated with plasma exchange.


Subject(s)
COVID-19 , Plasma Exchange , Stevens-Johnson Syndrome , Humans , COVID-19/complications , COVID-19/therapy , Hydroxychloroquine/adverse effects , RNA, Messenger , Stevens-Johnson Syndrome/etiology , Stevens-Johnson Syndrome/therapy , Vaccines, Inactivated/adverse effects , Child , COVID-19 Vaccines/adverse effects
20.
Curr Drug Saf ; 17(2): 83-89, 2022.
Article in English | MEDLINE | ID: covidwho-1910837

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) is a new strain of coronavirus. It is characterized by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It has quickly influenced all over the world since it spreads easily. Common symptoms are fever, cough, difficulty in breathing and muscle aches. Despite the urgent need to find an effective antiviral treatment, already available agents are being used alone or in combination all over the world. At the beginning of the pandemic, death rates of infection caused by COVID-19 are high but "is COVID-19 responsible for all deaths?", or "are there any contributions of the frequently used drugs in this period to these deaths?" Surely herd immunity plays a major role and has contributed to the decline in mortality rates. Meanwhile, it is kept in mind that due to safety concerns, changes have also been made in the dosage and combined use of frequently used drugs. OBJECTIVE: In this review, answers to two questions above and the safety of treatments, toxicities of agents involving chloroquine, hydroxychloroquine, remdesivir, favipiravir, lopiravir/ritonavir, sarilumab, tocilizumab, siltuximab, corticosteroids and bromhexine which are the most frequently used in Turkey and all over the world will be summarized. CONCLUSION: Among these drugs, favipiravir seems the most promising drug due to more tolerable adverse effects. More clinical trials with large sample sizes are needed to find the most effective and safe drug for COVID-19 treatment.


Subject(s)
COVID-19 , COVID-19/drug therapy , Humans , Hydroxychloroquine/adverse effects , Pandemics , SARS-CoV-2
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