A 4-week treatment of essential amino acids or placebo to participants with: 1) negative COVID-19 test with exposure, or 2) positive COVID-19 test and no or mild symptoms. The study team will measure change in symptoms. Participants will complete symptom surveys for 4 weeks and once at 8 and 12 weeks as well as pre- and post-assessments.

Type: Interventional

Start Date: May 2021

open study

The human immune system is designed to protect individuals from external sources of infection and internal cell mutation. It works effectively and efficiently until inflammation disturbs its functioning. Once compromised by inflammation, the immune system loses its capacity to recognize antigens and dependably defend the body against disease and illness. When COVID-19 invades humans, it causes an immune-storm (cytokine-storm) that can directly damage the organ(s), leading to death. The virus is an antigen - a trigger - but it is not the actual reason that causes organ failure and death; instead, it is the body's over immune reaction that is the cause. In attempting to protect the body, the immune system overreacts to the antigen, which includes the infected cells, which causes a cytokine-storm, and the subsequent and rapid shut down of the infected individual's organ(s)' structure, leaving the body without sufficient strength or time to fight back. When the medical herbs join the body, it can slow down the immune reaction. Medical herbs benefit the physical body; they protect the cells and organism structure and mediate the immune response, allowing the T cells to kill the virus (mutated or not) internally. Such success has been achieved by the All Natural Medicine Clinic during pre-clinical trials. This clinical study's goal is to demonstrate that the immune system can be rebuilt and retrained, using natural medicine (i.e., medical herbs), to kill the virus without causing the immune storm, and to explore the mechanism by which these medical herbs, which have been used for thousands of years for healing, achieve results.

Type: Interventional

Start Date: Feb 2021

open study

Patients who are severely ill with COVID-19 may benefit from receiving plasma infusions from donors who have recovered from the disease and are proven to no longer be infected. Efforts to initiate the collection and infusion of these products to high risk patients have been initiated around the world and the FDA has recently provided information about how this could be accomplished. As the Jefferson Blood Donor Center already has processes to collect, test and process blood, investigators are planning to make efforts to collect plasma for this use should it be necessary. The purpose of this study is to describe the process for identifying and collecting convalescent plasma from donors previously infected with the virus. The research portion on top of this standard blood product collection will the process of identification of subjects and processes by which blood products are processed in this special population. This protocol does not involve the administration of blood products to patients with COVID-19 infection.

Type: Interventional

Start Date: Apr 2020

open study

The purpose of this research is to identify whether or not Angiotensin Receptor Blockers (ARB) can halt the progression to respiratory failure requiring transfer into the intensive care unit (ICU), as well as halt mechanical ventilation in subjects with mild to moderate hypoxia due to the corona virus that causes COVID-19. Based on previous animal studies, the researchers hypothesize that the addition of an ARB is beneficial in abating acute lung injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia.

Type: Interventional

Start Date: Mar 2020

open study

A controlled trial of the drug tranexamic acid (TXA) in outpatients who were recently diagnosed with COVID-19. It is hypothesized that TXA will reduce the infectivity and virulence of the virus.

Type: Interventional

Start Date: Jun 2020

open study

This is a two-part study is to evaluate the multi-day safety, tolerability, and pharmacokinetics (PK) of orally administered GS-441524 in a healthy human volunteer.

Type: Interventional

Start Date: Jan 2021

open study

This study is to evaluate the feasibility and safety of treatment with related donor Human Leukocyte Antigen (HLA) matched or haploidentical allogeneic T regulatory cells in patients with COVID 19 induced ARDS. Study treatment will be administered in 1 to 2 doses, with the possibility of a second infusion given 14 days after the initial infusion.

Type: Interventional

Start Date: Mar 2021

open study

Study Objectives: To perform COVID-19 diagnostic and serologic testing on emergency medical personnel in Polk County to determine: 1. COVID-19 prevalence 2. Rate of convalesced personnel (+antibodies) 3. Rate of asymptomatic carriers

Type: Observational

Start Date: May 2020

open study

ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary research as well as clinical outcome data. However, if infection control or other restrictions limit the ability of the subject to return to the clinic, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir as assessed by the mechanical ventilation free survival by Day 29.

Type: Interventional

Start Date: Dec 2020

open study

This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.

Type: Interventional

Start Date: Jul 2020

open study

Objective: To assess whether adjunctive therapy of COVID-19 infection with atorvastatin reduces the deterioration in hospitalized patients and improves clinical outcome.

Type: Interventional

Start Date: Jun 2020

open study

Since December 2019 the world has been shaken with an enormous global threat: the Covid-19 pandemic. This new kind of coronavirus is generating an unprecedented impact both on the general population and on the healthcare systems in most countries. Health services are trying to expand their capacity to respond to the pandemic, taking actions such as increasing the number of beds; acquiring necessary equipment to provide intensive therapy (ventilators), and calling retired health professionals and health students so they can assist the overwhelmed health care workforce. Unfortunately, these organizational changes at health facilities, along with the fears and concerns of becoming ill with the virus or infecting their families, put an enormous emotional burden on workers in health services which may lead to negative outcomes on mental health in this population. Recent cross-sectional studies in China indicate that health service workers exposed to people with Covid-19 reported higher rates of depressive and anxious symptoms. This negative impact on mental health among health workers in China has also been informally reported in other countries where the Covid-19 pandemic has been devastating in its effects (such as Spain and Italy), as well as in countries where the pandemic is becoming a growing public health problem. This is particularly relevant in regions with fewer resources (Latin America, North Africa), where there are limited means and the response from the health system is usually insufficient. Moreover, it is necessary to study these negative effects longitudinally considering that some effects will appear over time (post-traumatic stress). The COVID-19 HEalth caRe wOrkErS (HEROES) study is a large, bottom-up, South-North initiative aimed to evaluate the impact of the COVID-19 pandemic on the mental health of health care workers (HCWs). HEROES encompasses a wide variety of academic institutions in 19 LMICs and 8 HICs, in partnership with the Pan American Health Organization (PAHO) and with support from the World Health Organization (WHO). The HEROES study is led by Dr. Rubén Alvarado at University of Chile, and Dr. Ezra Susser and Franco Mascayano at Columbia U Mailman School of Public Health.

Type: Observational

Start Date: Apr 2020

open study

Background: The human disease caused by SARS-CoV-2 is called COVID-19. In most cases, COVID-19 is a mild to moderate respiratory illness. But it can also be more severe and even lead to death. There is no vaccine to prevent SARS-CoV-2 infection. There is also no therapy to treat COVID-19. Researchers want to collect plasma from adults who have recovered from COVID-19, which may help them develop treatments. Objective: To collect anti-SARS-CoV-2 immune plasma from adult volunteers who have recovered from COVID-19. Eligibility: Males and females ages 18 to 70 who have a history of COVID-19 like illness or positive test for SARS-CoV-2, and have a minimum level of SARS-CoV-2 antibodies as specified by the study. Design: This study consists of 2 parts: 1) screening for SARS-CoV-2 antibody titer and eligibility to donate plasma and 2) plasma collection by apheresis. Study sites may participate in 1 part alone (either screening or plasma collection only) or both parts (screening and plasma collection). For screening part: Participants will be screened for their eligibility to join this research study with a medical history and physical exam. Their vital signs (blood pressure, heart rate, temperature, respiration rate) will be taken. Their weight and height will be recorded. They will give a blood sample for clinical laboratory tests of their general health and a research test for SARS-CoV-2 antibodies. They will discuss their history of COVID-19-like illness and any testing for SARS-CoV-2. They will be evaluated for their ability to donate plasma. For plasma collection part: Subjects meeting criteria for plasma donation and found to have high neutralizing antibody titers and who plan to donate plasma under this part of the study will be scheduled for 1 (and up to 20) plasma collection sessions. These will occur no less than 7 days apart. Prior to each donation, participants will have a brief physical exam and complete a donor history questionnaire. They will be asked about any current SARS-CoV-2 infection symptoms. At each donation, plasma will be taken through a standard apheresis procedure. For this, blood will be withdrawn through a needle placed in the participant's arm vein. A machine will separate the plasma from the red cells. The red cells will be returned to the participant, either through the same needle or through a second needle in the other arm. Participation may last up to 240 days.

Type: Observational

Start Date: Jun 2020

open study

This is a randomized, double-blind, placebo-controlled trial to assess the efficacy of zinc in a higher risk COVID-19 positive outpatient population.

Type: Interventional

Start Date: Dec 2020

open study

The proposed trial will obtain preliminary data on the feasibility of studying RTB101 as compared to placebo for COVID-19 post-exposure prophylaxis in adults age ≥ 65 years to inform the design of a subsequent pivotal trial.

Type: Interventional

Start Date: Oct 2020

open study

To assess the co-relation of COVID-19 in nasopharyngeal swabs and tears or saliva, and to determine duration of COVID-19 activity in ocular fluid and saliva by serial tests over 3 months.

Type: Observational

Start Date: Dec 2020

open study

The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalised patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.

Type: Interventional

Start Date: Jan 2021

open study

To evaluate the performance of the FDA EUA authorized Lucira COVID-19 All-In-One Test Kit for the qualitative detection of SARS-CoV-2 virus in nasal swab samples as compared to a known high sensitivity EUA RT-PCR among asymptomatic individuals. The comparator assay for this study is the Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay.

Type: Interventional

Start Date: Dec 2020

open study

The novel coronavirus (COVID-19) pandemic has caused an unprecedented stress on healthcare systems in affected countries, and in particular, on the healthcare workers at the frontline working directly with COVID-19 positive patients. Numerous lines of evidence support the damaging impact of stress on our immune systems which increases susceptibility to infection. Yet, the accurate measurement of immediate stress responses in real time and in naturalistic settings has so far been a challenge, limiting our understanding of how different facets of acute or sustained stress increases susceptibility. This study utilizes wearable technologies including an Oura smart ring as well as semi-continuous passive and active biometric measurements carried out using individuals' own smartphones equipped with applications to track and transmit key data to measure frontline workers stress and recovery during a uniquely stressful and high-risk work environment.

Type: Interventional

Start Date: May 2020

open study

The primary objective of this study was to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale on Day 11.

Type: Interventional

Start Date: Mar 2020

open study

This study generates robust clinical data to train ML/AI algorithms of the Sponsor's imPulse™ Una full-spectrum e-stethoscope for digital diagnostic feature synthesis of symptomatic SARS-CoV-2/COVID-19 biosignatures for rapid and accurate mass screening.

Type: Observational

Start Date: Oct 2020

open study

Acute respiratory distress syndrome (ARDS) is a major complication among patients with severe disease. In a report of 138 patients with COVID-19, 20% developed ARDS at a median of 8 days after the onset of symptoms, with 12.3% of patients requiring mechanical ventilation. Efficacious therapies are desperately needed. Supportive care combined with intermittent prone positioning may improve outcomes. Prone positioning (PP) of patients with severe ARDS (when combined with other lung-protective ventilation strategies) is associated with a significant mortality benefit. In addition, PP for >12 hours in severe ARDS is strongly recommended by clinical practice guidelines. The aim of this study is to compare the outcomes of prone positioning versus usual care positioning in non-intubated patients hospitalized for COVID-19.

Type: Interventional

Start Date: Apr 2020

open study

The PATCH trial (Prevention And Treatment of COVID-19 with Hydroxychloroquine) is funded investigator-initiated trial that includes 3 cohorts. Cohort 1: a double-blind placebo controlled trial of high dose HCQ as a treatment for home bound COVID-19 positive patients; Cohort 2: a randomized study testing different doses of HCQ in hospitalized patients; Cohort 3: a double blind placebo controlled trial of low dose HCQ as a preventative medicine in health care workers.

Type: Interventional

Start Date: Apr 2020

open study

The primary aim of this study is to provide and evaluate a phone-based intervention to improve relational and mental well-being during the COVID-19 crisis. This information also will help us understand how individuals are responding to COVID-19 and have the potential to inform psychological and policy level interventions.

Type: Interventional

Start Date: Apr 2020

open study

ACTT-3 will evaluate the combination of interferon beta-1a and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary outcome is time to recovery by Day 29.

Type: Interventional

Start Date: Aug 2020

open study