A Synthetic MVA-based SARS-CoV-2 Vaccine, COH04S1, for the Prevention of COVID-19 Infection
COVID-19 InfectionThis phase I trial evaluates the side effects and best dose of COH04S1, a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2 vaccine, for the prevention of COVID-19 infection. COVID-19 infection is caused by the SARS-CoV-2 virus. SARS-CoV-2 has demonstrated the capability to spread rapidly, leading to significant impacts on healthcare systems and causing societal disruption. COH04S1 was created by placing small pieces of SARS-CoV-2 DNA (the chemical form of genes) into synthetic MVA, which may be able to induce immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The purpose of this study is to determine the safety and the optimal dose of the COH04S1 vaccine.
Inflammatory Signal Inhibitors for COVID-19 (MATIS)
CoronavirusCovid191 moreThe Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS) study is a two-stage, open-label, randomised controlled trial assessing the efficacy of ruxolitinib (RUX) and fostamatinib (FOS) individually, compared to standard of care in the treatment of COVID-19 pneumonia. The primary outcome is the proportion of hospitalised patients progressing from mild or moderate to severe COVID-19 pneumonia. Patients are treated for 14 days and will receive follow-up assessment at 7, 14 and 28 days after the first study dose. Patients with mild or moderate COVID-19 pneumonia will be recruited. Initially, n=171 (57 per arm) patients will be recruited in Stage 1. Following interim analysis to assess the efficacy and safety of the treatments, approximately n=285 (95 per arm) will be recruited during Stage 2.
General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to COVID-19...
Post-traumatic Stress DisorderMoral InjuryIt is expected that large numbers of healthcare workers will experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. The purpose of this study is to find interventions which are helpful in treating psychological distress in healthcare workers caring for COVID-19 patients. There are two phases of the study. All participants will take part in Phase I, which consists of 4 sessions over a two-week period of either a narrative writing intervention or a medical music intervention. Participants will be randomly assigned to the narrative writing intervention or medical music intervention. After Phase I, participants will be re-assessed. Healthcare workers who meet criteria for PTSD will be given the option to participate in Phase II of the study, in which they will be offered a choice between one of two evidence-based treatments for PTSD: Interpersonal Therapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minute sessions scheduled twice weekly. Participants will be allowed to choose a preferred treatment in Phase II. After Phase II participants will complete a final assessment concluding the study. All interventions will be offered using distance technology.
Proof of Principle Study to Evaluate the Safety, PK, Viral Shedding and Efficacy of Pentarlandir™...
Coronavirus Disease 2019This is a clinical trial to evaluate the safety, PK, viral shedding and clinical effects of Pentarlandir™ UPPTA in patients with early COVID-19. Approximately 90 ambulatory subjects with mildly symptomatic early COVID-19, who have been diagnosed with COVID-19 within the prior 4 days will be enrolled.
Ketotifen and Indomethacin Combination Treatment Clinical Trial for COVID-19
COVID-19 Respiratory InfectionThe purpose of this study is to evaluate the safety and effectiveness of ketotifen and indomethacin taken together to improve symptoms related with COVID-19. Ketotifen and indomethacin are medications approved by the Food and Drug Administration (FDA) to treat diseases other than COVID-19. Their use in this study is investigational, meaning they have not been approved by the FDA to treat COVID-19.
COVID-19 Vaccines in Patients With Chronic Liver Disease
Liver Disease ChronicSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020.Patients with chronic liver disease (CLD) are at higher risk of mortality and morbidity due to COVID-19. Despite there is a large number of clinical trials of COVID-19 vaccines, only a few participants with chronic liver diseases were included.
Safety and Immunogenicity of COVID-19 Vaccination in Patients With Cancer
Patients With CancersCOVID-191 moreSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with cancers may be at higher risk than those without cancer for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of COVID-19 vaccination for patients with cancer.
Phase 1 Study to Assess Safety, Tolerability, PD, PK, Immunogenicity of IV NTR-441 Solution in Healthy...
Covid19This first-in-human clinical study is a Phase 1a/ 1b, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and PK/PD of NTR-441 in healthy subjects and patients with COVID-19 after single ascending IV infusion doses and multiple ascending IV infusion doses.
Phase 2a MIB-626 vs. Placebo COVID-19
Covid19Stage 1 Acute Kidney InjuryThe proposed phase 2a trial will determine whether MIB-626 treatment in adults with COVID-19 infection and stage 1 acute kidney injury is more efficacious than placebo in preventing worsening of kidney function, as assessed by longitudinal changes in serum creatinine concentration, and in attenuating the inflammatory response to the infection.
SOLIDARITY Finland Long-COVID (Remdesivir Long-term Follow-up Study of COVID Patients)
Covid19SOLIDARITY Finland Long-COVID trial assesses the effects of remdesivir + standard of care (SoC) vs. only SoC on long-COVID symptoms and quality of life (QoL) using questionnaires at one and two years post-discharge. Objectives i) Long-COVID symptoms To investigate the effect of remdesivir (vs. SoC) on the occurrence of symptoms that have been associated with the long-COVID syndrome. The questionnaires will take place 1 and 2 years after the hospital admission. The symptom questionnaire - that will be completed by patients at one and two years - measures basic patient information (age, height, weight, smoking status, major comorbidity, and working status) and a wide variety of potential long-COVID-symptoms and their bother (1. Fatigue; 2. Attention deficits; 3. Memory problems; 4. Sleeping difficulties; 5. Depressive mood; 6. Anxiety; 7. Dizziness; 8. Headache; 9. Tinnitus; 10. Paresthesias; 11. Changes in taste/smell perceptions; 12. Postexertional malaise; 13. Palpitations; 14. Chest discomfort; 15. Nausea; 16. Skin rash; 17. Joint aches; 18. Muscle pains; 19. Continuous cough; 20. Respiratory tract mucous discharges) in remdesivir and usual care arms ii) Quality of life EQ-VAS: to compare patients' quality of life in remdesivir and usual care arms. EQ-5D-5L questionnaire assesses the following domains: 1. Mobility; 2. Self-care; 3. Usual activities; 4. Pain and discomfort; 5. Anxiety and depression; 6. The VAS of subjective perception of overall health. Additionally (at 1 or 2 years; depending on future funding and ethical approval decisions; currently the study has ethical approval for long-COVID and quality of life assessments only): The Finnish healthcare registries (Statistics Finland Mortality Database and the HILMO Care Register for Health Care) will be used to estimate long-term mortality and incidence of major comorbidity in remdesivir and usual care arms Lung function will be assessed using spirometry and diffusing capacity, as well as the six-minute walk test (6 mwt) in remdesivir and usual care arms Whole-genome genotyping will be performed for a genome-wide association study to investigate genetic correlates of long-COVID-19 -symptoms in remdesivir and usual care arms UPDATE 02.02.2022: Primary outcomes will comprise the following: EQ-VAS EQ-5D-5L, summary Does the patient feel recovered from COVID-19-infection at one year or not? (question no. 10) Fatigue (questionnaire, question no. 14) Exertional dyspnea (question no. 12)