COVID-19 Clinical Trials and Expanded Access

This study aims to examine the association between gut microbiota composition and themagnitude and duration of immune response in subjects who have received differentCOVID-19 vaccines in Hong Kong and to identify the differences compared to those COVID-19recovered subjects.

Covid-19 is an additional stressor Black women have to deal with that may interfere withhypertension self-care management. Social connectedness is a source of resilience forBlack women to promote mental and physical health. Unfortunately, in the face of theCovid-19 pandemic, social distancing is a challenge further isolating Black women fromtheir networks. How is social connectedness to manage stress and emotional well-being ina social-distancing society for Black women with hypertension? The research team proposeda synchronous web-based version of Enhanced Co-Created Health Education InterventioN(eCo-CHIN) that build the success and best practices derived from the originalintervention. A Covid-19 session will be included as a way of helping Black women tomaintain resilience and self-care during stressful times. The eCo-CHIN intervention isinnovative and timely because the research team are using a synchronous platformpreparing Black women on how to deal with Covid-19 while taking care of self. The primaryinvestigator for this pilot study (Dr. Wright) is a Black Early Stage Investigator andformer KL2 (career development) awardee. The interdisciplinary research team has theexpertise and resources to deliver this Enhanced Co-CHIN intervention.

Since initial reports of a novel coronavirus emerged from Hubei province, China, theworld has been engulfed by a pandemic with over 3 million cases and 225,000 deaths by30th April 2020. Health care systems around the world have struggled to cope with thenumber of patients presenting with COVID-19 (the disease caused by the SARS-CoV-2 virus).Although the majority of people infected with the virus have a mild disease, around 20%experience a more severe illness leading to hospital admission and sometimes requiretreatment in intensive care. People that survive severe COVID-19 are likely to havepersistent health problems that would benefit from rehabilitation.Pulmonary rehabilitation (PR) is a multidisciplinary program which is designed to improvephysical and social performance and is typically provided for people with chronic lungconditions. PR courses typically last 6-12 weeks with patients attending classes once ortwice weekly and consist of exercise and education components. PR is known to improvesymptoms (e.g. breathlessness), quality of life and ability to exercise in those withlung conditions. Breathlessness is a very common symptom reported by people presenting tohospital with COVID-19 and loss of physical fitness will be very common. Using existingpulmonary rehabilitation programmes as a model, we have developed a tele-rehabilitationprogramme (a programme that will be delivered using video link to overcome the challengesfaced by social distancing and shielding advice) for people that have been critically illwith COVID-19. In order to prove whether people benefit from this tele-rehabilitationprogramme after being admitted to hospital following COVID-19 we would need to perform alarge clinical trial. However, before doing this it is important for us to answer somekey questions: - How many people that have been admitted to hospital and needed intensive care treatment for COVID-19 still report breathlessness, fatigue, cough and limitation of activities after being discharged from hospital? - Is it possible to recruit these people to a trial of tele-rehabilitation after hospital discharge? - Are people willing and able to perform tele-rehabilitation in their own home using video-link to connect with their therapist? - Are there other rehabilitation needs that are commonly encountered by people requiring intensive care treatment for COVID-19 that could be addressed by tele-rehabilitation that the programme doesn't currently address? Investigators will perform a small study called a feasibility trial to answer these questions and gather some early information about possible benefits of tele-rehabilitation. Based on our understanding of other similar diseases, doctors and therapists think that people will benefit from rehabilitation after COVID-19. The investigators therefore want to test a trial design that makes sure that everyone gets the treatment. This type of trial is called a feasibility, wait-list design randomised controlled trial. People with breathlessness and some limitation of activities will be selected at random to receive tele-rehabilitation within 2 weeks or to wait 6-8 weeks before starting. how many people were eligible to take part, how many agreed to take part and the symptoms and rehabilitation needs that they have will be assessed. Investigators will then monitor symptoms and ability to exercise at the start and end of the trial and before and after tele-rehabilitation.

A Phase I, double- blinded, randomized, placebo- controlled study to test the safety ofLomecel-B in Adults suffering from mild to severe acute respiratory distress syndrome(ARDS) due to COVID-19 resultant from 2019-nCoV coronavirus infection, or resultant frominfluenza virus infection.

Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated withan increased risk preterm birth, cesarean section, and maternal critical care. This studywill examine the factors that impede testing for SARS-CoV-2 (the causative virus amongpregnant women), help determine optimal testing strategies by evaluating the necessity oftesting for asymptomatic disease in pregnancy, inform prenatal care plans by assessingthe full impact of infection, and contribute to a provider's ability to counsel women andcreate prenatal care plans if they are pregnant or considering pregnancy.

This study will collect information on immune response and adverse events aftervaccination against coronavirus disease (COVID-19) in a vulnerable patient cohort.Understanding the ability or disability to mount a protective immune response aftervaccination will help to counsel patients during the pandemic and support decisions onwhom to vaccinate and to identify patients who require other measures to protect themfrom COVID-19.

The purpose of this study is to advance the scientific understanding of how a prenatalCOVID-19 infection and associated psychological distress influences infantneurodevelopment. This project will aim to shed light on how families and childdevelopment are impacted by the current COVID-19 pandemic and will work to better supportthese families and children as they grow.

Background: Coronavirus disease 2019 (COVID-19) has affected almost every country in theworld, especially in terms of health system capacity and economic burden. People fromsub-Saharan Africa (SSA) often face interaction between human immunodeficiency virus(HIV) infection and non-communicable diseases such as cardiovascular disease. Role of HIVinfection and anti-retroviral treatment (ART) in altered cardiovascular risk isquestionable and there is still need to further carry out research in this field.However, thus far it is unclear, what impact the COVID-19 co-infection in people livingwith HIV (PLHIV), with or without therapy will have. The ENDOCOVID project aims toinvestigate whether and how HIV-infection in COVID-19 patients modulates the time courseof the disease, alters cardiovascular risk, and changes vascular endothelial function andcoagulation parameters/ thrombosis risk.Methods: In this long-term study, cardiovascular research on PLHIV with or without ARTwith COVID-19 and HIV-negative with COVID-19 will be carried out via clinical andbiochemical measurements for cardiovascular risk factors and biomarkers of cardiovasculardisease (CVD). Vascular and endothelial function will be measured by brachial arteryflow-mediated dilatation (FMD), carotid intima-media thickness (IMT) assessments, andretinal blood vessel analyses, along with vascular endothelial biomarkers andcoagualation markers. The correlation between HIV-infection in COVID-19 PLHIV with orwithout ART and its role in enhancement of cardiovascular risk and endothelialdysfunction will be assessed. Potential changes in these endpoints by COVID-19 will befollowed for 4 weeks across the three groups (PLHIVwith or without ART and HIVnegatives).Impact of project: The ENDOCOVID project aims to evaluate in the long-term thecardiovascular risk and vascular endothelial function in PLHIV thus revealing animportant transitional cardiovascular phenotype in COVID-19.

Primary Objective:Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acutemoderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPDSecondary Objectives: - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD

People have had to make a lot of changes to their lives due to the COVID-19 healthcrisis. Most experts agree that social distancing and other safety measures have taken atoll on people s mental health. Amish and Mennonite communities often have largefamilies. They may have limited access to health care. Their lifestyle is based oninteraction and group events rather than technology. So people in Amish and Mennonitecommunities may experience the pandemic in their own special ways.Objective:To describe the relationship between stress related to the pandemic and self-ratedmeasures of mental health symptoms and distress among Amish and Mennonite people withbipolar disorder and related conditions, and their family members.Eligibility:Adults ages 18 and older who are taking part in the NIMH AMBiGen study (80-M-0083).Design:Participants will be mailed 4 surveys. One survey will ask about depression symptoms. Onesurvey will ask about mania symptoms. One survey will assess a broad range ofpsychological problems. One survey will assess the impact of COVID-19 on their mentalhealth. They will fill out the surveys 4 times over 24 months.The surveys will not include participants names, just codes. This will help protectprivacy.Data collected in 80-M-0083 will be used. This includes data about participants genes,medical conditions, and assessments.Participants will get an 800 number they can call to speak to the research team. They canalso write to the team if they prefer. Participants who wish will get referrals formental health services. Participation will last up to 24 months. There will be an optionfor recontact in the future.