Predi-COVID is a prospective cohort study composed of people positively tested forCOVID-19 in Luxembourg, followed digitally for monitoring participants' health evolutionand symptoms at home. Participants will be actively followed for 14 days from the time ofconfirmation of diagnosis, whether they are at the hospital or at home in isolation orquarantine. Short evaluations will be also performed at week 3 and week 4 and thenmonthly for a period up to 12 months to assess potential long term consequences ofCOVID-19. A subsample of 200 participants will be contacted to integrate complementaryclinical data and collect samples.The study aims at identifying factors associated with the COVID-19 disease severity.COVID-19 patients with severity criteria will be compared to patients with mild diseasemanaged at home.A deep phenotyping related to the symptoms of the disease as well as biosampling allowingfor laboratory-based and computational analytics will be performed.

The spectrum of the COVID-19 disease ranges from benign to asymptomatic to viralpneumopathy that can progress to acute respiratory distress syndrome (ARDS). Thehost-pathogen relationships and the physiopathological mechanisms underlying the clinicalaggravation of COVID-19 patients remain misunderstood. The project aim is to create aprospective cohort of biological samples collected from well characterized COVID-19patients. This project aims first to identify based on these samples an early immunesignature predictive of clinical worsening of COVID-19 patients in order to improve theirmanagement, and secondarily to better understand pathophysiological mechanisms underlyingthe different phases of the disease in order to identify innovative therapeutic targetsand vaccine perspectives.

RECOVERY is a randomised trial of treatments to prevent death in patients hospitalisedwith pneumonia.The treatments being investigated are:COVID-19: Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin,Colchicine, IV Immunoglobulin (children only), Convalescent plasma,Casirivimab+Imdevimab, Tocilizumab, Aspirin, Baricitinib, Empagliflozin, Sotrovimab,Molnupiravir, Paxlovid or Anakinra (children only)Influenza: Baloxavir marboxil, Oseltamivir, Low-dose corticosteroids - DexamethasoneCommunity-acquired pneumonia: Low-dose corticosteroids - Dexamethasone

: Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developedSAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc]bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluatethe safety, immunogenicity, and pharmacokinetics of SAB-185 in ambulatory participantswith COVID-19.

COVID-19 is a community acquired pneumonia caused by infection with a novel coronavirus,SARS CoV2 and is a serious condition with high mortality in hospitalised patients, forwhich there is no currently approved treatment other than supportive care. Urgentinvestigation of potential treatments for this condition is required.This protocol describes an overarching and adaptive trial designed to provide safety,pharmacokinetic (PK)/ pharmacodynamic (PD) information and exploratory biologicalsurrogates of efficacy which may support further development and deployment of candidatetherapies in larger scale trials of COVID-19 positive patients receiving normal standardof care.Given the spectrum of clinical disease, community based infected patients or hospitalisedpatients can be included. Products requiring parenteral administration will only beinvestigated in hospitalised patients. Patients will be divided into cohorts, a)community b) hospitalised patients with new changes on a chest x-ray (CXR) or a computedtomography (CT) scan or requiring supplemental oxygen and c) hospitalised requiringassisted ventilation. Participants may be recruited from all three of these cohorts,depending on the experimental therapy, its route of administration and mechanism ofaction. The relevant cohort(s) for any given therapy will be detailed in thetherapy-specific appendix.Candidate therapies can be added to the protocol and previous candidates removed fromfurther investigation as evidence emerges. The trial will be monitored by an independentData Monitoring Committee (DMC) to ensure patient safety.Each candidate cohort will include a small cohort of patients randomised to candidatetherapy or existing standard of care management dependent on disease stage at entry.Cohort numbers will be defined in the protocol appendices.This is a Phase IIa experimental medicine trial and as such formal sample sizecalculations are not appropriate.

An International Multi-Centre Randomised Adaptive Platform Clinical Trial to Assess theClinical, Virological and Immunological Outcomes in Patients with SARS-CoV-2 Infection(COVID-19).

The goal of this project is to rapidly screen promising agents, in the setting of anadaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase2 platform design, agents will be identified with a signal suggesting a big impact onreducing mortality and the need for, as well as duration, of mechanical ventilation.

This study will provide access to investigational anti-SARS-CoV-2 human convalescentplasma for pediatric patients with underlying medical conditions (cardiovascular disease,lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have hada high-risk exposure. Study participants will be transfused once with compatibleconvalescent plasma obtained from an individual who has recovered from documentedinfection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected.

The objectives of this intermediate-size expanded access protocol are to assess thesafety and efficacy of remestemcel-L in participants with MIS-C associated with COVID-19.

This is a pilot phase, open label, non-randomized study for the treatment of ARDS inpatients infected with COVID-19. Subjects will be enrolled and treated with one dose ofmesenchymal stem cells and follow-up will occur 90 days post-treatment.