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Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome
AgelessRx
Covid19
Long COVID-19
Post-COVID-19 Syndrome
Pilot study into low dose naltrexone (LDN) and NAD+ for treatment of patients with
post-COVID-19 syndrome. expand
Pilot study into low dose naltrexone (LDN) and NAD+ for treatment of patients with post-COVID-19 syndrome. Type: Interventional Start Date: Jan 2021 |
Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)
Merck Sharp & Dohme LLC
Coronavirus Disease (COVID-19)
This study aims to evaluate the safety, tolerability and efficacy of molnupiravir
(MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to
placebo as assessed by the rate of sustained recovery through Day 29. expand
This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the rate of sustained recovery through Day 29. Type: Interventional Start Date: Oct 2020 |
Nebulised Heparin in Patients With Severe COVID-19
Australian National University
Covid19
Respiratory Failure
The Can nebulised HepArin Reduce morTality and time to Extubation in Patients with
COVID-19 Requiring mechanical ventilation Meta-Trial (CHARTER-MT) is a prospective
collaborative individual patient data analysis of randomised controlled trials and early
phase studies. Individual studies are being... expand
The Can nebulised HepArin Reduce morTality and time to Extubation in Patients with COVID-19 Requiring mechanical ventilation Meta-Trial (CHARTER-MT) is a prospective collaborative individual patient data analysis of randomised controlled trials and early phase studies. Individual studies are being conducted in multiple countries, including Australia, Ireland, the USA, and the UK. Mechanically ventilated patients with confirmed or strongly suspected SARS-CoV-2 infection, hypoxaemia and an acute pulmonary opacity in at least one lung quadrant on chest X-ray, will be randomised to nebulised heparin 25,000 Units every 6 hours or standard care (open label studies) or placebo (blinded placebo controlled studies) for up to 10 days while mechanically ventilated. All trials will collect a minimum core dataset. The primary outcome for the meta-trial is ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation. Individual studies may have additional outcomes. Type: Interventional Start Date: Nov 2020 |
Tafenoquine in Patients With Mild to Moderate COVID-19
60 Degrees Pharmaceuticals LLC
COVID 19 Disease
A clinical study to assess the efficacy and safety of oral tafenoquine compared to
placebo in patients with mild to moderate COVID 19 disease. expand
A clinical study to assess the efficacy and safety of oral tafenoquine compared to placebo in patients with mild to moderate COVID 19 disease. Type: Interventional Start Date: Feb 2021 |
Study to Evaluate the Efficacy and Safety of AstroStem-V in Treatment of COVID-19 Pneumonia
Nature Cell Co. Ltd.
Covid19 Pneumonia
This study is an open-label, single-arm study to evaluate the safety and efficacy of
Astrostem-V, allogenic adipose tissue derived mesenchymal stem cells (AdMSC), in patients
with COVID-19 pneumonia. After each subject completes 12-Weeks visit (Visit 12) and the
data management team confirms all individual... expand
This study is an open-label, single-arm study to evaluate the safety and efficacy of Astrostem-V, allogenic adipose tissue derived mesenchymal stem cells (AdMSC), in patients with COVID-19 pneumonia. After each subject completes 12-Weeks visit (Visit 12) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis. Type: Interventional Start Date: Oct 2022 |
A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19
Bellerophon Pulse Technologies
COVID-19
Coronavirus
Coronavirus Infection
A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of
pulsed inhaled iNO compared to placebo in subjects with COVID-19. expand
A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed inhaled iNO compared to placebo in subjects with COVID-19. Type: Interventional Start Date: Jul 2020 |
Registry of Seraph®-100 Microbind® Affinity Blood Filter for COVID-19 Under EUA
Children's Hospital Medical Center, Cincinnati
COVID-19
SARS-CoV 2
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a global pandemic
and is associated with significant morbidity and mortality. The mortality rate for
COVID-19 patients admitted to an intensive care unit (ICU) who require mechanical
intubation is approximately 75%. While the... expand
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has caused a global pandemic and is associated with significant morbidity and mortality. The mortality rate for COVID-19 patients admitted to an intensive care unit (ICU) who require mechanical intubation is approximately 75%. While the pathophysiology of severe COVID-19 has yet to be fully understood, it is possible that a combination of high viral loads and an overactive dysregulated inflammatory response may contribute. Therefore, the clearance of SARS-CoV-2 virus and cytokines could provide a more opportunistic environment for the innate immune system to clear the virus and establish lasting immunity. The Seraph®-100 Microbind® Affinity Blood Filter (Seraph®-100) is an extracorporeal broad-spectrum sorbent hemoperfusion filter for removing virus and cytokines from the blood. The FDA authorized an Emergency Use Authorization (EUA) for treatment of severe COVID-19 with the Seraph®-100. As part of the EUA, this registry study will collect de-identified data to assess safety and efficacy on the use of Seraph®-100 Microbind® Affinity Blood Filter in the treatment of COVID-19 patients. Type: Observational [Patient Registry] Start Date: Jun 2020 |
Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection
Karyopharm Therapeutics Inc
Coronavirus Infection
The main purpose of this study is to evaluate the activity of low dose oral selinexor
(KPT-330) and to evaluate the clinical recovery, the viral load, length of
hospitalization and the rate of morbidity and mortality in participants with severe
COVID-19 compared to placebo. The study had 2 arms and... expand
The main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo. The study had 2 arms and evaluated selinexor 20 mg + standard of care (SoC) and placebo + SoC. As the treatment for COVID-19 is rapidly evolving, the SoC varied over time and across regions of the world. Type: Interventional Start Date: Apr 2020 |
Food Effect Study to Evaluate the Effect of High-Fat Meal on the Relative Bioavailability of PF-07321332...
Pfizer
Healthy Participants
This is a Phase 1, open label, single dose, randomized, 2-treatment, 2-sequence, 2-period
crossover study to evaluate the effect of high-fat meal on the relative bioavailability
of PF-07321332 boosted with ritonavir following single dose oral administration of
PF-07321332 in combination with ritonavir... expand
This is a Phase 1, open label, single dose, randomized, 2-treatment, 2-sequence, 2-period crossover study to evaluate the effect of high-fat meal on the relative bioavailability of PF-07321332 boosted with ritonavir following single dose oral administration of PF-07321332 in combination with ritonavir using 150 mg tablet formulation of PF-07321332 in healthy adult participants. Type: Interventional Start Date: Nov 2021 |
A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic...
Novartis Pharmaceuticals
COVID-19
The purpose of this study is to establish the antiviral efficacy of ensovibep against
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the
optimal dose, and demonstrate its clinical value for treating COVID-19 in adult
ambulatory patients. expand
The purpose of this study is to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for treating COVID-19 in adult ambulatory patients. Type: Interventional Start Date: May 2021 |
The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of...
Nitric Oxide Innovations LLC
COVID-19
This study is a multi-center, randomized, double blinded, prospective, placebo controlled
study. Patients upon diagnosis of COVID-19 (Corona Virus Disease-19) will be eligible to
participate in the study. The purpose of this study is to find out the side effects and
ability to take the study drug,... expand
This study is a multi-center, randomized, double blinded, prospective, placebo controlled study. Patients upon diagnosis of COVID-19 (Corona Virus Disease-19) will be eligible to participate in the study. The purpose of this study is to find out the side effects and ability to take the study drug, Nitric Oxide (NO) lozenges when taken twice daily by mouth. If this study shows that the drug has no or few, acceptable side effects, it will then include up to 840 participants to find out if the drug can reduce bad outcomes of COVID-19 infection (hospitalization, ICU admission, death). In each part of the study, half of the subjects will receive the study drug and the other half will be given a placebo (inactive pill). Type: Interventional Start Date: Nov 2020 |
Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized With COVID-19
Sorrento Therapeutics, Inc.
Covid-19
Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus
SOC in subjects hospitalized with COVID-19 expand
Study to assess the safety and efficacy of STI-5656 (Abivertinib Maleate) plus SOC versus SOC in subjects hospitalized with COVID-19 Type: Interventional Start Date: Oct 2020 |
Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19...
ModernaTX, Inc.
SARS-CoV-2
This clinical study will assess the safety, reactogenicity, and immunogenicity of 2 dose
levels of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-COV-2) vaccine in
adults 18 years of age or older. expand
This clinical study will assess the safety, reactogenicity, and immunogenicity of 2 dose levels of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-COV-2) vaccine in adults 18 years of age or older. Type: Interventional Start Date: May 2020 |
Anti-SARS Cov-2 T Cell Infusions for COVID 19
Baylor College of Medicine
SARS-CoV 2
Viral Infection
COVID 19
This is a dose-finding safety trial followed by a randomized pilot trial comparing
administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment
in hospitalized patients with COVID19 who are at high risk of requiring mechanical
ventilation.
The SARS-CoVSTs lines have... expand
This is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients with COVID19 who are at high risk of requiring mechanical ventilation. The SARS-CoVSTs lines have been made at Baylor College of Medicine from healthy donors who have made a full recovery from COVID19. These cell lines were frozen for later use and will be thawed and used to treat patients who meet the eligibility criteria. Type: Interventional Start Date: Nov 2020 |
Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)
Beyond Air Inc.
Corona Virus Infection
COVID-19
SARS-CoV 2
Nitric Oxide
Respiratory Disease
The purpose of this open label, randomized, study is to obtain information on the safety
and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients
with COVID-19 caused by SARS-CoV-2. expand
The purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2. Type: Interventional Start Date: Jun 2020 |
Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)
Unity Health Toronto
ARDS
This is a multicenter randomized controlled clinical trial with an adaptive design
assessing the efficacy of setting the ventilator based on measurements of respiratory
mechanics (recruitability and effort) to reduce Day 60 mortality in patients with acute
respiratory distress syndrome (ARDS).
The... expand
This is a multicenter randomized controlled clinical trial with an adaptive design assessing the efficacy of setting the ventilator based on measurements of respiratory mechanics (recruitability and effort) to reduce Day 60 mortality in patients with acute respiratory distress syndrome (ARDS). The CAVIARDS study is also a basket trial; a basket trial design examines a single intervention in multiple disease populations. CAVIARDS consists of an identical 2-arm mechanical ventilation protocol implemented in two different study populations (COVID-19 and non-COVID-19 patients). As per a typical basket trial design, the operational structure of both the COVID-19 substudy (CAVIARDS-19) and non-COVID-19 substudy (CAVIARDS-all) is shared (recruitment, procedures, data collection, analysis, management, etc.). Type: Interventional Start Date: Nov 2020 |
Information Provision and Consistency Framing to Increase COVID-19 Booster Uptake
University of California, Los Angeles
COVID-19
Vaccines
This study investigates different ways to elevate intentions to get the COVID-19 booster
via text-based reminders, including providing information about the booster and
leveraging the consistency principle. The proposed randomized controlled trial will
examine the impact of these reminders on booster... expand
This study investigates different ways to elevate intentions to get the COVID-19 booster via text-based reminders, including providing information about the booster and leveraging the consistency principle. The proposed randomized controlled trial will examine the impact of these reminders on booster uptake. Type: Interventional Start Date: Oct 2022 |
Effects of Prompt to Bundle COVID-19 Booster and Flu Shot
University of California, Los Angeles
COVID-19
Vaccines
This randomized controlled trial investigates whether text-based reminders can increase
the bivalent COVID-19 booster uptake and whether text-based reminders that mention the
opportunity to bundle the COVID-19 booster with the flu shot within the same appointment
can increase take-up of both the COVID-19... expand
This randomized controlled trial investigates whether text-based reminders can increase the bivalent COVID-19 booster uptake and whether text-based reminders that mention the opportunity to bundle the COVID-19 booster with the flu shot within the same appointment can increase take-up of both the COVID-19 booster and the flu vaccine. Type: Interventional Start Date: Oct 2022 |
Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2
Pfizer
Pneumococcal Disease
COVID-19
SARS-CoV-2 Infection
Study of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2
administered at the same visit or each vaccine given alone expand
Study of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2 administered at the same visit or each vaccine given alone Type: Interventional Start Date: May 2021 |
A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against...
BioNTech SE
SARS-CoV-2 Infection
COVID-19
This study will compare the safety and tolerability of lyophilized BNT162b2 presented in
single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine
whether the immune response is noninferior. Separately, the study will also describe the
safety and immunogenicity of frozen-liquid... expand
This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior. Separately, the study will also describe the safety and immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of specification and ready to use BNT162b2 (the immediate manufacturing precursor to the lyophilate). Additionally, the study will describe the safety and immunogenicity of an additional dose of frozen liquid BNT162b2 to participants who already received the 2-dose schedule of lyophilized BNT162b2. - 2-dose schedule (separated by 21 days) - At a dose of 30µg (as studied in the Phase 2/3 study C4591001) - In healthy adults 18 through 55 years of age - The duration of the study for each participant will be approximately 2 months (3 visits in total) - The study will be conducted in the United States Type: Interventional Start Date: Apr 2021 |
A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots...
BioNTech SE
SARS-CoV-2 Infection
COVID-19
This is a Phase 3, randomized, observer-blind study in healthy individuals.
The primary study will evaluate the safety, tolerability, and immunogenicity of the
SARS-CoV-2 RNA vaccine candidate (BNT162b2):
- As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches)
-... expand
This is a Phase 3, randomized, observer-blind study in healthy individuals. The primary study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (BNT162b2): - As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches) - As a 20-microgram dose, administered from 1 of the manufacturing lots - As a 2-dose (separated by 21 days) schedule - In people 12 through 50 years of age The booster study will evaluate the safety, tolerability, and immunogenicity of 2 SARS-CoV-2 RNA vaccine candidates (BNT162b2 and BNT162b2.B.1.351): - Each as a 30-microgram dose - Each as a 1-dose booster vaccine, administered approximately 3 months after Dose 2 - In people 18 through 50 years of age Type: Interventional Start Date: Feb 2021 |
Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)
University of California, Los Angeles
COVID-19
Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care
per UCLA treating physicians versus current care per UCLA treating physicians alone
(control arm). Importantly, this adaptive trial design allows for patients in either
study arm to receive other investigational... expand
Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per UCLA treating physicians versus current care per UCLA treating physicians alone (control arm). Importantly, this adaptive trial design allows for patients in either study arm to receive other investigational drugs for COVID-19 as new science emerges. Type: Interventional Start Date: May 2020 |
Evaluation of the Clinical Impact of Corticosteroid Duration on SARS-CoV-2 (COVID-19 WHO)
Methodist Health System
Covid 19
The purpose of this project is to evaluate the clinical impact of the use of
glucocorticoids beyond 10 days for patients with critical COVID-19 at MDMC. expand
The purpose of this project is to evaluate the clinical impact of the use of glucocorticoids beyond 10 days for patients with critical COVID-19 at MDMC. Type: Observational Start Date: Oct 2021 |
COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability
MP Biomedicals, LLC
Sars-CoV-2 Infection
COVID-19
SARS-CoV-2 rapid antigen over the counter usability study. expand
SARS-CoV-2 rapid antigen over the counter usability study. Type: Interventional Start Date: Oct 2021 |
COVID-19 MP Biomedicals SARS-CoV-2 Ag OTC: Clinical Evaluation
MP Biomedicals, LLC
SARS-CoV2 Infection
COVID-19
SARS-CoV-2 rapid antigen over the counter clinical performance evaluation expand
SARS-CoV-2 rapid antigen over the counter clinical performance evaluation Type: Interventional Start Date: Dec 2021 |
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