Novel Agents for Treatment of High-risk COVID-19 Positive Patients

  • STATUS
    Recruiting
  • End date
    May 8, 2022
  • participants needed
    240
  • sponsor
    Susanne Arnold
Updated on 8 July 2021
diabetes
cancer
azithromycin
COPD
covid-19
SARS
hydroxychloroquine
ivermectin

Summary

This is a multi-arm, phase II trial for rapid efficacy and toxicity assessment of multiple therapies immediately after COVID19 positive testing in high-risk individuals. Therapies include stand-alone or combination treatment with hydroxychloroquine, azithromycin, ivermectin, or camostat mesilate, artemesia annua. The hypothesis of this study is that the addition of agents that inhibit viral entry or replication of SARS-CoV-2 virus replication in will be devoid of additional moderate to severe toxicities, will prevent clinical deterioration, and will improve viral clearance in high risk individuals.

Description

Coronavirus Disease 2019 (COVID-19) is a highly contagious disease, caused by a novel enveloped RNA beta-coronavirus, also known as severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). The first case of this unprecedented outbreak "pneumonia of unknown etiology" was reported in Wuhan City, Hubei Province, China on December 8th, 2019 and reported to the World Health Organization (WHO) on December 31st, 2019. WHO declared a COVID-19 global emergency on January 30, 2020, and then categorized the outbreak as a pandemic on March 11, 2020. As of April 22, 2020, more than 2,628,894 confirmed cases of COVID-19 worldwide and 182,740 people globally have died from COVID-19 since it emerged in China, according to the data from Johns Hopkins University.

While the majority of patients with COVID-19 develop mild or uncomplicated illness, approximately 20-30% of hospitalized patients have required intensive care support and 5% of those have multi-organ failure or shock. The case fatality rate ranges from 1 to 4% and it is higher among those with pre-existing comorbid conditions such as cardiovascular disease, diabetes mellitus, obesity, chronic respiratory disease, hypertension and cancer. The vast majority of patients present with fever (83-99%), cough (59-82%), fatigue (44-70%), anorexia (40-84%), shortness of breath (31-40%), sputum production (28-33%), myalgias (11-35%). Less than 10% of patients will present with headache, confusion, rhinorrhea, sore throat, hemoptysis, vomiting, or diarrhea. Anosmia or ageusia proceeding the onset of respiratory symptoms has been anecdotally reported.

To date, treatments for COVID-19 in high risks individuals remain experimental and therapeutic strategies to deal with the infection are at best supportive, with prevention aimed at reducing transmission in the community as the best weapon. No proven therapies have been demonstrated to prevent the progression of COVID-19 to severe illness and this is a critical unmet need for high-risk individuals and warrants study. Recently, the Infectious Disease Society of America has made recommendations for the treatment of patients with COVID-19, focusing on inpatient care, and recommending randomized trials where possible as the best step to improve treatment outcomes and to increase our understanding of this coronavirus pandemic. Discoveries in this area may inform clinicians on effective treatment for low-risk individuals who progress to severe illness, as well.

Details
Condition Sars-CoV2, *COVID-19 Infection, SARS COV2, COVID-19; Cardiovascular Diseases, Corona Virus Disease 2019(COVID-19), Hospitalized Patients With Covid-19 Pneumonia, Pathogen Infection Covid-19 Infection, COVID-19 Infection, Anxiety Related to the COVID-19 Pandemic, COVID-19 Pneumonia, Coronavirus Disease (COVID-19), COVID-19, Hydroxychloroquine Sulfate, Treat and Prevent Covid-19 Infection, Old Age, Usability, Visio Telephony, Confinement, Covid-19, *COVID-19, COVID-19, *Corona Virus Infection, Covid-19, COVID-19 by SARS-CoV-2 Infection, SARS-CoV-2 (COVID-19) Infection, Community-acquired Pneumonia, Influenza, COVID-19, Severe Coronavirus Disease (COVID-19), Acute Respiratory Distress Syndrome Caused by COVID-19, Use of Stem Cells for COVID-19 Treatment
Treatment hydroxychloroquine, Ivermectin, Artesunate, Camostat Mesilate, Hydroxychlorquine and Azithromycin, Hydroxychloroquine and Ivermectin, Hydroxychloroquine and Azithromycin, Artemesia annua
Clinical Study IdentifierNCT04374019
SponsorSusanne Arnold
Last Modified on8 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years
Laboratory-confirmed SARS-CoV-2 infection within the past 7 days or the presence of symptoms or physical examination signs providing high probability of COVID-19 disease
Patients must have adequate organ and marrow function measured within the last 6 months
Subjects must have at least one of the following high-risk features for clinical
deterioration
Hypertension
Diabetes Mellitus
Moderate to severe Chronic Obstructive Pulmonary Disease, Emphysema, Cystic Fibrosis, or Asthma
Cancer patients who have received any immunosuppressive drugs within a year from enrollment
Sickle Cell disease or thalessemia
Age > or = 50
BMI > or = 30
Living in a nursing home or long-term facility
Underlying serious heart condition as determined by the treating physician
Immunocompromised subject as defined by the treating physician or COVID-19 Telehealth Treatment Team

Exclusion Criteria

Severe or life threating COVID
Weight less than 45 kg
Pregnant or breast-feeding females
Subjects on dialysis or with creatinine clearance < 45 ml/min
Existing DMID Toxicity Scale for Determining Severity of Adverse Events grade 3 or greater hepatic failure
Previously documented moderate or severe retinopathy or macular degeneration
Uncontrolled Seizure disorder
Prolonged QT, defined as QTc 470 milliseconds for men and as QTc 480 for women using Bazett's formula
Known allergy to artesunate, artemisia annua, hydroxychloroquine, macrolides, 4-aminoquinolines, camostat mesilate, or other agents to be used in the trial
Currently receiving any study medications for other indications
Concurrent use of medication that would cause drug-drug interactions
Patients with psychiatric illness/social situations that would limit compliance
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