Clinical Trials and Expanded Access

The investigators aim to characterise Coronavirus Disease 2019 (COVID-19) in every age group. On the one hand, emphasis is put on the initial presentation, clinical course, outcome and the therapy used. On the other hand further investigations regarding viral and bacterial coinfections, and response of the immune system will be conducted. This study should serve to improve the understanding of COVID-19, to identify risk factors for a severe clinical course and to obtain further insights into pathophysiology of this new infectious disease.

The Coronavirus Disease 2019 (COVID-19) pandemic has placed tremendous stress on the global economy since its outbreak in December 2019. Currently, with nearly 1.3 million confirmed cases, there is still no effective way to contain the disease. The transmission of COVID-19 occurs via direct (prolonged close interaction, within 2 meters for more than 30 minutes) and indirect (fomites) contacts. Locally, the risk of COVID-19 infection in household contacts of confirmed cases is about 4%. These at-risk individuals are identified through contact tracing and infectious may be preventable using post-exposure-prophylaxis (PEP). However, there has yet to be a single effective, safe, and affordable pharmacological agent with such capabilities. Hydroxychloroquine (HCQ) is a cheap anti-malarial and immunomodulatory agent which may potentially be used as PEP against COVID-19. HCQ is capable of blocking the invasion and intracellular replication of the virus. Existing studies have reported efficacy of HCQ in treating COVID-19, with reduced time to clinical recovery and few reports of patients suffering from significant side effects. However, existing studies are largely limited by their small sample sizes. Furthermore, there has yet to be a published trial on HCQ's role in PEP. This cluster randomized trial will evaluate the safety and efficacy of oral HCQ PEP, taken over for 5 days, in reducing the number of infected household contacts of confirmed COVID-19 patients under home quarantine. Comparison will be made between HCQ PEP (treatment group) and no treatment (control group). Subjects will be followed up over a course of 28 days, with daily symptom monitoring conducted over phone calls. Positive outcomes from this study will provide a means for us to battle the COVID-19 pandemic.

The purpose of this research is to see if the DPP4 inhibitor linagliptin, an oral medication commonly used to treat type 2 diabetes,can help with diabetes control and reduce the severity of the COVID-19 infection

The overall objective of the study is to determine the therapeutic effect and tolerance of Anakinra in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Anakinra (ANA) is a recombinant human decoy IL-1Ra and therefore blocks IL-1α and IL-1β. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Anakinra administration to patients enrolled in the COVIMUNO-19 cohort. Anakinra will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Anakinra will receive standard of cares. Outcomes of Anakinra -treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.

Pakistan is a resource restraint country, it's not possible to carry out coronavirus testing at mass scale. Simple cost effective intervention against the present pandemic is highly desirable. For patients: Identifying an antiviral gargle that could substantially reduce the colonies of COVID-19 residing in mouth and oro-naso-pharynx is likely to reduce the viral load. Such reduction in the viral load through surface debridement could aid the effective immune response in improving the overall symptoms of the patients. For dentists: This study is important because the nature of the dental profession involves aerosol production, carrying out dental work on asymptomatic patients carrying coronavirus puts the entire dental team at a great risk of not only acquiring the infection but also transmitting it to the others. Antiviral gargles could be used by dentist and their auxiliaries as prophylaxis. For physicians and nurses: The risk of morbidity and mortality is high among physicians and nurses involved in the screening and management of Covid-19 patients. Globally, over 215 physicians and surgeons have died while taking care of Covid-19 patients. The cause of death is attributed to high exposure of viral load. The antiviral gargles and nasal lavage can decrease the fatalities among doctors and nurses. Thus, patients, physicians, nurses and dentists, all could be benefited with this findings of this study.

The utilization of AlloSure to help guide immunosuppression management in solid organ transplant recipients diagnosed with COVID-19

Experimental intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours of referral to an Intensive Care Unit. Control intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) as rescue therapy following failure of conventional therapy for ARDS. This conventional therapy will be standardized to reduce bias. Duration of intervention per patient: varies, depending on severity of pulmonary compromise Follow-up per patient: Until hospital discharge Accompanying measures: Serum Samples and bronchoscopy samples of patients included into the trial for secondary analysis of inflammatory parameters and potential biomarkers

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19) emerged at December 2019 in Wuhan, China, and soon caused a large global outbreak. The delayed treatment for many chronic diseases, due to the concern of SARS-CoV-2 infection, is an increasing serious problem. Here we investigate the safety of chemotherapy for patients with gynecological malignancy in Wuhan, the center of high-risk regions of COVID-19.

The study aims to evaluate the working environments of individuals working from home during the covid-19 outbreak and the effect of the working environments on their musculoskeletal system. The study will include 500 people between the ages of 18-65 who works from home (works in the office before isolation) as a part of Covid-19 isolation measure. The working environment of the individuals participating in the study will be evaluated with The Rapid Office Strain Assessment (ROSA). Musculoskeletal symptoms will be analysed by using the Standardised Nordic Questionnaries (NMQ). Pain will be analysed by using Visual Analogue Scale (VAS)

The emerging field of stem cell therapy holds promise of treating a variety of diseases. Especially the mesenchymal stromal cells from bone marrow or adipose tissue (ASCs) have proven their potential for regenerative therapy in patients with ischemic heart disease. Both of these cell types have putative immunomodulatory properties, as they have demonstrated their ability to evade recognition and actively suppress the immune system. This knowledge is transferred into studies with COVID-19 patients having severe pulmonary dysfunction, to modify the virus induced immunological and inflammatory activity involved in the progression of disease often leading to prolonged ICU stay and in some occasion's death. We will conduct a clinical trial in which patients with COVID-19 and severe pulmonary symptoms will be randomized to either placebo or treatment with allogeneic CSCC_ASCs from adipose tissue. The aim is to assess the impact of CSCC_ASCs on the activated immune system and clinical efficacy on pulmonary function. The perspective is that this new information can be of pivotal importance and potentially be a paradigm shift for the clinical problems and severe outcome seen in some patients with severe COVID-19 and other severe diseases with Acute Respiratory Distress Syndrome.