Active clinical trials for "COVID-19"

The COVID-19 pandemic has increased mental health concerns worldwide, and young adults are at higher risk of experiencing increased psychological distress due to the pandemic. University students face compounding stressors during the pandemic, such as online and remote learning, economic insecurity, and uncertain career prospects. This study aims to evaluate the effectiveness of an online modular prevention program featuring integrated elements of Acceptance and Commitment Therapy (ACT) and Islamic spirituality in reducing the psychological distress and increasing the psychological flexibility, self-compassion, and resilience of Muslim university students in Malaysia.

Currently, the efficacy of COVID-19 vaccination in immunodeficient patients is unknown. Here the investigators aim to evaluate the efficacy of COVID-19 vaccines in immunodeficient patients compared to healthy controls. The investigators will assess the humoral and cellular response to COVID-19 vaccination in these subjects in detail. Furthermore, factors associated with good response to vaccination will be identified. The results of this study will help to guide future recommendations on COVID-19 vaccination in this population.

COVID-19 affected more than 9 million of people with more than 130 thousand death in India. If adequate preventive and therapeutic measures are not taken, India has very high risk of affecting million of more people with high mortality because of the large population along with very high population density. At present there are no definitive therapeutic drugs or vaccine available for the treatment and prevention of SARS-CoV-2 infection. Symptomatic and supportive care are being given to COVID-19 cases along with isolation and quarantine measure are being taken for the suspected individual at risk for COVID-19 to limit the spread of the SARS-CoV-2 infection . Among the all the drugs being used for the treatment of COVID-19, hydroxychloroquine (HCQ), has given some rays of hope to battle against this deadly pandemic. HCQ has some anti viral effect against SARS-CoV in vitro. HCQ is quite safe and being used in rheumatology patients for lifelong without much side effect, so it allow for higher dose without any significant side effects and drug-drug interaction. Recently published clinical trial suggested HCQ can be used for the therapeutic purpose of the SARS-CoV-2 infection and many governments have endorsed that due to lack of any other better alternative drugs. Indian council of medical research (ICMR) has advised for HCQ prophylaxis for the people who are at risk for developing SARS-CoV-2 infection, all asymptomatic health care workers involved in taking care of suspected or confirmed COVID-19 cases and all asymptomatic household contacts of laboratory confirmed COVID-19 cases. With this encouragement an open level clinical trial was conducted on HCQ as post exposure prophylaxis (PEP) for the prevention of COVID-19 in asymptomatic high risk house hold contact of the laboratory confirmed COVID-19 cases. The result was very promising showing absolute risk reduction of around 9% in participant who received PEP with HCQ as compared to the control group and there was no serious adverse event. But there is still conflicting scientific data to prove or disprove the efficacy of HCQ for the treatment and prophylaxis for SARS-CoV-2 infection. Being a tertiary care center PGIMER is catering many states which include Punjab, hariyana, himachal Pradesh, Uttara khand, Uttar Pradesh. This put the institute to handle highest burden of suspected cases of SARS-CoV-2 in northern India. So, this double blind clinical trial has been planned to evaluate the efficacy of HCQ as PEP for the prevention of COVID-19 in asymptomatic individuals who are at risk for SARS-CoV-2 infection. The asymptomatic individual with direct contact with laboratory confirmed COVID-19 cases will be randomized into one PEP group and one control/placebo group as per inclusion and exclusion criteria. Individual who will not give consent for HCQ prophylaxis and those with contraindication for HCQ therapy like, hypersensitivity to HCQ or 4-aminoquinolone derivatives, patients with known retionopathy, cardiac arrhythmia, G6PD deficiency, psoriasis and pregnancy will be excluded from the study. All symptomatic individual and all health care workers related to suspected or proven COVID-19 and who received CoVID-19 vaccine will be excluded from the study. The PEP group will receive tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once weekly for 3 weeks (total cumulative dose of 2000 mg). The control group will receive placebo instead of HCQ. Both the groups will receive standard care of therapy in the form of home quarantine for 2 weeks along with social distancing and personal hygiene. The participants will be followed up for 4 weeks telephonically or physically as and when required and will be enquired regarding development of any COVID-19 symptoms like fever, cough, sore throat, shortness of breath, diarrhoea, myalgia. During follow up nasopharyngeal swab of the participants will be taken for processing reverse transcription polymerase chain reaction (RTPCR) for the detection of SARS-CoV-2 RNA to confirm the CoVID-19. Samples for RTPCR will be taken when any asymptomatic participants becomes symptomatic and by the 5-14 days of contact in asymptomatic participants through in-hospital visit at the institute's COVID-19 screening clinic.

The MEXICO study is an observational study that aims to identify underlying mechanisms contributing to exercise intolerance in the presence of persistent COVID-19 symptoms (Long COVID).

Background: COVID-19 is consistently spreading throughout the world, and the number of recovered patients is steadily increasing. Accordingly, a significant number of individuals will develop persisting post-COVID symptoms, while many of them will report on lasting fatigue. The main objective of the current study is to assess risk factors for the development of post-COVID-19 fatigue symptoms. As a secondary aim, the current study is intended to identify pathophysiology and explanatory mechanisms for the post-COVID-19 fatigue. Study design and population: a nested case-control study will be conducted at Rabin Medical Center (RMC), Beilinson Hospital. RMC runs a post-COVID-19 clinic for adult (age ≥18 years) recovered individuals (diagnosed using a polymerase chain reaction test from a nasopharyngeal sample), who are invited for a comprehensive medical evaluation. During a visit, all individuals undergo pulmonary function testing and an evaluation by an infectious diseases physician, a pulmonologist, and a social worker. The cohort of recovered COVID-19 individuals evaluated at RMC will serve as the population from which the current study participants will be consecutively sampled. The cases would be defined as such if report on lasting fatigue symptoms which appeared following COVID-19, while at least two months have elapsed since COVID-19 diagnosis and the lasting fatigue symptoms are present for at least six weeks. The controls would be defined as those that did not report on fatigue symptoms at any time point since one month following their diagnosis with COVID-19. Evaluation protocol of cases and controls: All participating individuals (cases and controls) will be assessed following the study protocol. The assessment will be conducted as follows: First assessment meeting (approximately one hour long) in which the participant will undergo physical examination and blood tests, fill the study questionnaires [demographic, clinical and post-COVID fatigue questionnaire; sleep assessment questionnaires (Epworth sleepiness score [ESS], Pittsburg sleep quality index [PSQI], Insomnia severity index (ISI)]) and depression severity questionnaire (the patient health questionnaire-9 [PHQ-9]), and conduct cognitive fatigue task. Second assessment meeting: (approximately one hour long) in which the participants will undergo a cardiopulmonary stress test (CPET). Data collection: The main dependent variable will be the presence of continuing fatigue symptoms. The independent variables included demographic and clinical characteristics. The demographic variables will include: age at diagnosis, sex, marital status and number of children, occupational status (employed, unemployed, or retired), education (number of years at school and higher education), and occupation. The clinical variables will include: smoking status, alcohol and cannabis consumption, basic physical function (independent, limited in certain activities, dependent in activities of daily living, or bedridden), background illnesses, and pharmacotherapy. The acute COVID-19 history will be also collected: disease severity according to the WHO criteria, symptoms (sore throat, nasal congestion, headache anosmia/disguesia, cough, shortness of breath, chest pain, gastrointestinal symptoms, and myalgia), need for hospitalization, hospital complications (veno-thromboembolism, super-imposed bacterial infections), for individuals who were not hospitalized - the site of isolation (home, hotel or another isolation facility) will be collected, time from onset to symptoms resolution, pharmacotherapy directed at COVID-19, and information of other household or family members who were also diagnosed. Statistical methods: Demographic and clinical variables of the patients with fatigue symptoms (cases) and control group (free from fatigue symptoms) will be compared using bivariate and multivariable conditional logistic regression models. Independent variables will be selected to be included in the multivariable model based on the bivariate analysis. Odds ratios and 95% confidence intervals will be obtained from the conditional logistic regression models. P<0.05 will be considered statistically significant. Sample size calculation: Disease severity may serve as a potential risk factor for the development of lasting fatigue symptoms. A preliminary analysis revealed that in our cohort of recovered COVID-19 patients, 20% were hospitalized due to their disease's severity. We will therefore assume that the proportions of individuals required hospitalization during the acute phase were 30% and 10% of the cases and controls, respectively. It is also likely that approximately two thirds of our sample would report on persisting fatigue. Under these assumptions, a sample size of 153 individuals (102 in the cases group and 51 in the control group) will yield a statistical power of 80% at a significance level of 5% for detecting a difference of 0.2 between two proportions.

In Lower middle-income countries (LMICs) like Pakistan with limited health care facilities the gravity of COVID 19 is severe. Effective management and implementation of processes and planning is imperative. In surgical procedures additional time is required to prepare for surgery in a suspected/confirmed case of COVID-19 in daily routines regardless of whether surgery would happen. Therefore, for effective management of surgical procedures the Aga Khan University, Karachi, Pakistan has established a COVID testing algorithm for effective management of the surgical patients. The objectives of the study are To evaluate the outcomes of COVID testing algorithm established for surgery patients presenting to Aga Khan University Karachi, Pakistan To compare the outcomes among patients who underwent elective versus emergency surgery.

Case-series and cohort studies have shown the feasibility of reperfusion therapies in patients with ischemic stroke and COVID-19, but due to the absence of a contemporary control group of non-COVID-19 patients, small sample size or lack of long-term outcome assessment, concerns regarding safety and efficacy of these treatments remain to be clarified. Taking into account its limitations, some studies documented higher rates of endovascular treatment complications such as clot fragmentation with distal embolization and vessel re-oclusion, to be more difficult to achieve recanalization after endovascular treatment, and higher rates of any intracerebral hemmorhage. The investigators aim is to assess in a large, multicenter and international cohort, the safety and outcomes of acute reperfusion therapies in patients with ischemic stroke and COVID-19, by comparison with a contemporary control group of patients with ischemic stroke and without COVID-19 from the same centers.

The impact of the current Covid-19 pandemic on healthcare workers is enormous. This longitudinal study investigates the prevalence of mental health problems and the quality of life of healthcare workers during and after the Covid-19 pandemic. Underlying risk factors are also examined. Health care workers of the different Covid-19 cohort and transit wards, as well as the intensive care unit and (psychiatric) emergency services of the Ghent university hospital will be included, as well as the health care workers of 6 non-Covid-19 wards.

The authors hypothesize that the SARS-CoV-2 virus can affect the kidneys, causing them to be damaged. The present study aims to explain the mechanisms of kidney injury in patients diagnosed with COVID-19.

The general aim of this study is to estimate the rate of disease progression for adults testing positive for SARS-CoV-2. The primary endpoint for this study and the basis for sample size is hospitalization or death during the 28 day follow-up period. In some locations special facilities are being built/utilized for quarantine/public health reasons for those who are SARS-CoV-2 positive. Hospitalization is defined as a stay for at least 18 hours, irrespective of reason, at a hospital or one of these special facilities after study enrollment. Secondary outcomes include participant-reported health status and change in severity of dyspnoea.