COVID-19 Clinical Trials and Expanded Access

SARS-CoV-2 is the agent responsible for a new infectious respiratory disease called Covid-19 (for CoronaVirus Disease 2019) which is mainly characterized by potentially severe and fatal lung damage. The severity of the clinical signs associated with this pathology requires the admission to hospital of approximately 20% of patients, 5%-10% of whom will be admitted to intensive care. The most severe cases of this pathology begin with dyspnea which worsens rapidly around the 7th-10th day of the disease into an acute respiratory distress syndrome (ARDS) which requires the patient to be put under mechanical ventilation in the intensive care unit and is responsible for the majority of deaths. Certain biological parameters suggest a massive and brutal release of cytokines (interleukins IL-6, IL-8 and IL-10 mainly) secondary to a syndrome of macrophagic activation mainly in the pulmonary level. Several therapeutic trials aimed at reducing or controlling this immune storm are in progress (anti IL-6 antibodies, anti r IL6 Ab, corticosteroids). Molecular hydrogen acts on the final path of this complex inflammatory cascade by inhibiting the cellular action of reactive oxygen species. Its early use combined with nasal oxygen therapy could prevent this worsening of the respiratory system, so could be likely to limit the risk of overflow of intensive care services during the pandemic and save lives. The aim of this study is to evaluate the safety and the Dose Limiting Toxicity (DLT) of hydrogen therapy delivered by a nasal cannula in addition to conventional oxygen therapy in patients with moderate Covid-19

Some patients with COVID-19 have sequelae after the acute phase of infection. These sequelae can be physical (dyspnea, exercise intolerance, abnormal fatigue) but also psychic (anxiety, depression). Systemic sequelae have also been observed in pulmonary, cardiac, hepatic, renal, nervous or immune systems. Respiratory rehabilitation (RR) is indicated in these patients to help their complete recovery without sequelae. These patients' arrival and sanitary constraints imposed by COVID-19 changed the organization of Health Care Centers (HCC). Risk of contagiousness after the acute phase of infection still exists. Consequently, patients must respect a quarantine time on their arrival in HCC and then have no contact with other HCC patients to respect the barrier rules and social distancing measures. HCC accommodation capacities are reduced and this is to the detriment of patients with chronic diseases for whom RR is essential. Certain HCCs saturation can also be responsible for a non-proposal of RR in the care pathway of patients after COVID-19. To cope with the new constraints imposed by Covid-19 pandemic, telemedicine is being developed in the affected industrial countries. Some SRH physicians are starting to offer post-COVID-19 patients the possibility of carrying out a tele-rehabilitation program (TRR). Such a telemedicine program has been validated for people with respiratory failure. It allows the patient to follow his care program without leaving his home and it does not require the visit from a health professional. In addition to reducing the inflow of post COVID-19 patients in HCC, it allows fragile patients to respect social distancing. It could also contain virus spread virus on the territory by reducing patient movements. When choosing between RR and TRR, the clinician must ask himself two questions. Is TRR as efficient as RR for post-COVID-19 patients? Is there a profile of patients for whom either method gives better results? This study proposes to evaluate both methods: a 4-week TRR program vs a conventional RR program in post COVID-19 patients with sequelae. If the hypothesis that both methods have similar effects is verified, this would allow the generalization of the prescription of TRR. The benefits will be individual with greater access to respiratory rehabilitation for post COVID-19 patients. There will also be collective public health benefits by maintaining sufficient access to HCC for patients with chronic diseases.

The purpose of this study is to measure how well monoclonal antibodies work, either alone or in combination, against the virus that causes COVID-19. Study drug(s) will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 or 24 weeks and includes at least 1 visit to the study site, with the remainder of assessments performed in the home, local clinic, or by phone.

Most mental health problems emerge by age 14, often leading to chronic impairments and adverse impacts for individuals, families, and societies. Any action-focused path to reducing the need-to-access gap will require moving beyond the dominant settings, formats, and systems that have constrained intervention delivery to date. In a fully-online trial, youths ages 13-16 will be randomized to 1 of 3 self-administered single-session interventions (SSIs): a behavioral activation SSI, targeting behavioral MD symptoms; an SSI teaching growth mindset, targeting cognitive MD symptoms; or a control SSI. The investigators will test each SSI's relative benefits, versus the control, on depressive symptoms and proximal outcomes such as hopelessness. Results will reveal whether SSIs that were designed to address behavioral versus cognitive symptoms differentially benefit adolescents with elevated depressive symptoms.

This is the first-in-human phase 1/2a trial of the intravenous administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals. It will evaluate the safety, pharmacokinetic profile, immunogenicity, and antiviral activity of DZIF-10c.

This is the first-in-human phase 1/2a trial of the inhaled administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals. It will evaluate the safety, pharmacokinetic profile, immunogenicity, and antiviral activity of DZIF-10c.

Hypothesis: The apelin/APJ system is involved in the protection of the lung affected by the COVID-19 by interacting with the SARS-coV-2 entry door: the Angiotensin I Converting Enzyme 2 (ACE2) and the renin-angiotensin system (ras). Elevated systemic levels of apelins and ACE2 activity are associated to less critical forms of COVID-19 and characterized by less pulmonary hyperpermeability and inflammation. Goals: Main: In COVID-19+ patients, to establish the basic knowledge of 1) apelins and related systems (ras and degradation enzymes, of which ACE2) pheno-dynamic profile in bloodstream, 2) pulmonary hyperpermeability profile by biomarker's assessment i) comparison of SARS vs. lesser COVID-19 respiratory injury, and with non COVID-19 ARDS and non ARDS acute respiratory condition. Secondary: To set up links between basic and progressive clinical data (data collection system APEL-COVID).

PATIENTS WHO ARE ADMITTED TO HOSPITALIZATION IN HCOR AND WHO HAVE THE CONFIRMED DIAGNOSIS OF CORONA VIRUS, WILL BE ASKED TO CONSENT TO PARTICIPATE IN THIS STUDY THAT INTENDS TO STUDY THE EFFECTIVENESS OF THE REMOTE INTERCESSION PRAYER IN COMBATING THIS DISEASE.

Uganda hosts 1.4 million refugees, making it Sub-Saharan Africa's largest refugee host community and the third largest globally. Adolescents and young people (AYP) comprise half of the world's 70.8 million forcibly displaced persons, yet they are understudied in pandemics, including in COVID-19. Poverty, overcrowded living conditions, and poor sanitation likely elevate forcibly displaced persons' COVID-19 risks by limiting their ability to practice mitigation strategies. There continue to be significant knowledge gaps regarding the implementation and effectiveness of behaviour change interventions on improving COVID-19 prevention practices (i.e. hand and respiratory hygiene, physical distancing). mHealth (healthcare delivered by mobile phones) is cost-effective, aligned with how youth learn and socialize, vital for physical distancing, and has been used for COVID-19 messaging in other low- and middle-income countries. Nested within an ongoing HIV self-testing cluster-randomized trial, this study aims to develop, implement, and evaluate the effectiveness of an mHealth intervention in increasing COVID-19 prevention practices with displaced/refugee AYP aged 16-24 in Kampala, Uganda. Participants will be enrolled in a 8-week mHealth social group intervention program that is informed by the RANAS (Risks, Attitudes, Norms, Abilities, and Self-Regulation) approach to Water, Sanitation, and Hygiene. Using a pre-test/post-test design, this study will assess changes in participants' self-efficacy (e.g. ability, confidence, adherence) in COVID-19 prevention practices.

An early stage trial to check how safe and tolerable, as well as how the body handles continuous daily use of Active IMP over 28 days in healthy volunteers.