COVID-19 Clinical Trials and Expanded Access

A phase I/II single-blinded, randomised, multi-centre study to determine efficacy, safetyand immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administeredintramuscularly (IM) into the deltoid region of the arm

This is a randomized, double-blind placebo-controlled trial to investigate the efficacyand safety of tradipitant 85 mg orally given twice daily to treat inflammatory lunginjury associated with severe or critical COVID-19 infection.On evaluation for enrollment, participant will need to meet all inclusion and exclusioncriteria. If participant consents, they will be randomized 1:1 to treatment with eithertradipitant 85 mg PO BID or placebo in addition to standard of care for COVID-19infection as per the protocol at the treating hospital. NEWS 2 will be assessed atscreening and daily following randomization. Inflammatory lab markers as detailed shouldbe collected once per day in the morning, preferably at the same time every morning. Allenrolled participants will have whole blood collected for whole genome sequencing.

COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, includingFibrotic Lung Disease due to inflammatory and reactive protein secretions damagingpulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up..March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas ofNew York-New Jersey, Washington, and California.Immediate attention is turned to testing, diagnosis, epidemiological containment,clinical trials for drug testing started, and work on a long-term vaccine started.The recovering patients are presenting with mild to severe lung impairment as a result ofthe viral attack on the alveolar and lung tissues. Clinically significant impairment ofpulmonary function appears to be a permanent finding as a direct result of theinterstitial lung damage and inflammatory changes that accompanied.This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascularfraction (cSVF) deployed intravenously to examine the anti-inflammatory and structuralpotential to improve the residual, permanent damaged alveolar tissues of the lungs.

This study is an adaptive, randomized, open-label, controlled clinical trial, incollaboration with countries around the world through the World Health Organization.

This is an double-blind, randomized, placebo controlled phase III study in hospitalizedsubjects with confirmed SARS-CoV-2.

This is a Phase II interventional study testing whether treatment withhydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19

Randomized open label clinical trial carried out at study centers in Sweden, includingKarolinska University Hospital, S:t Göran Hospital, Danderyd Hospital and VästmanlandsHospital. Patients with COVID-19 who are hospitalized with oxygen therapy are eligiblefor inclusion. Subjects are randomized to 14 days of inhalation with ciclesonide 360 µgtwice daily or to standard of care. Primary outcome is duration of received supplementaloxygen therapy. Key secondary outcome is a composite outcome of death and receivedinvasive mechanical ventilation within 30 days.

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

Nitazoxanide has been shown to have a clinical efficacy against severe acute respiratorysyndrome coronavirus 2; ivermectin has also demonstrated a remarkable experimentalefficacy with a potential to be used for Coronavirus disease 2019.

The study researchers think that a medication called N-acetylcysteine can help fight theCOVID-19 virus by boosting a type of cell in your immune system that attacks infections.By helping your immune system fight the virus, the researchers think that the infectionwill get better, which could allow the patient to be moved out of the critical care unitor go off a ventilator, or prevent them from moving into a critical care unit or going ona ventilator.The US Food and Drug Administration (FDA) has approved N-acetylcysteine to treat theliver side effects resulting from an overdose of the anti-inflammatory medicationTylenol® (acetaminophen). N-acetylcysteine is also used to loosen the thick mucus in thelungs of people with cystic fibrosis or chronic obstructive pulmonary disease (COPD).This study is the first to test N-acetylcysteine in people with severe COVID-19infections.