Hydroxychloroquine and Lopinavir/ Ritonavir to Improve the Health of People With COVID-19: "The Hope Coalition - 1"

Last updated: January 25, 2021
Sponsor: Cardresearch
Overall Status: Active - Recruiting

Phase

3

Condition

Common Cold

Respiratory Syncytial Virus (Rsv) Infection

Covid-19

Treatment

N/A

Clinical Study ID

NCT04403100
COVID19_AMB_Brasil
  • Ages > 18
  • All Genders

Study Summary

The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV viral replication in experimental severe acute respiratory symptoms models and have similar activity against SARS-CoV2. Although widely used in studies of critically ill patients, to date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed patients with COVID-19 and mild symptoms.

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients with RT-PCR diagnosis of COVID-19 or a clinical condition compatible with COVID-19and respiratory symptoms, presenting: A. Persistent dry cough associated with axillary temperature > 37.7 Celsius; OR B. Recent onset of Flu-like Respiratory Symptoms associated with dry cough OR C. Tomographic image compatible with COVID 19 infection; 2. Men and women aged > 50 years OR: Patients over 18 years of age with at least one of thefollowing criteria

  • Diabetes requiring oral medication or insulin.
  • Arterial hypertension requiring at least 01 oral medication for treatment
  • Known cardiovascular diseases (CHF of any etiology, documented Coronary ArteryDisease, Clinically overt heart disease)
  • Symptomatic chronic lung disease and/ or medically controlled
  • Patients with a history of transplantation
  • Patient with stage IV chronic kidney disease or on dialysis.
  • Patients on current Immunosuppression and/or using corticosteroid therapy (equivalentto at least 10 mg of oral prednisone per day)
  • Willingness to comply with study related procedures
  1. Ability to provide informed consent before any protocol-related procedures.

Exclusion

Exclusion Criteria:

  1. RT-PCR exam for COVID-19 negative during the screening visit.
  2. Patients with an acute respiratory condition compatible with COVID-19 beinghospitalized;
  3. Patients with an acute respiratory condition and with moderate to high probability ofnot being a COVID infection 19;
  4. Dyspnea secondary to other acute and chronic respiratory causes or infections (eg,decompensated Chronic Obstructive Pulmonary Disease, acute bronchitis, pneumonia,primary pulmonary arterial hypertension);
  5. Severe respiratory clinical condition, presenting at least ONE of the criteria below:
  6. Respiratory Rate> 28 / min;
  7. Arterial Oxygen Saturation < 92% with nasal oxygen therapy at 10 l/ min;
  8. PaO2 / FIO2 <300 mmHg
  9. History of Cardiac Arrhythmia or Long QT Syndrome; 5. Use of Medications that are knownto prolong QTc: Citalopram, Venlafaxine, Bupropion and with no possibility of suspensionduring the period of investigational medical product administration. 6. Inability to takeoral medications; 7. Patients on continuous use of Amiodarone and / or PGE5 Inhibitors (Ex .: Sildenafil and similar). 8. Use of Digoxin, Cyclosporine, Cimetidine, Tamoxifen. 9. Useof anticonvulsants, antifungals, immunosuppressants other than corticotherapy. 10. Use ofHydroxychloroquine for other indications 11. Use of chemoprophylaxis for malaria. 12.Psoriasis in a form other than cutaneous 13. Porphyria 14. Use of protease inhibitors,ritonavir or Cobicistat 15. Clinical history of Liver Cirrhosis or Child-Pugh Cclassification; 16. Patients with a history of degenerative retinal diseases (patients withretinal diseases due to diabetes and hypertension can participate in the research); 17.Patient with a clinically relevant history of hearing loss; 18. Patients with known severedegenerative neurological diseases and / or severe mental illness; 19. Inability of thepatient or representative to give consent or adhere to the procedures proposed in theprotocol; 20. Known hypersensitivity and / or intolerance to Hydroxychloroquine. 21.Hypersensitivity and / or intolerance Lopinavir / Ritonavir

Study Design

Total Participants: 1968
Study Start date:
June 03, 2020
Estimated Completion Date:
February 01, 2021

Study Description

In December 2019 a series of viral pneumonia cases were reported in the city of Wuhan, China. A new subtype of coronavirus has been identified as the causative agent of this condition. On February 11, 43,103 cases had already been described and on this day the World Health Organization (WHO) named this disease as COVID-19. With. The disease had spread out to several countries on different continents and on March 11, WHO declared a state of worldwide pandemic. Today (April 25, 2020) there are 2,719,897 cases and 187,705 deaths documented, with a global case-fatality ratio of 6.9%.

To date, no treatment has been identified as effective in combating this disease which has been identified as with high mortality, therefore there are no specific therapeutic options. So far, efforts have been focused on the treatment of patients hospitalized with dyspnea and, although several promising drugs are being evaluated, none has demonstrated effectiveness in reducing morbidity and mortality at this stage of the disease, suggesting that perhaps the best time to use medications either before the onset of severe symptoms of respiratory distress.

Thus, we propose the use of two drugs which experimentally have shown activity against SARS-CoV2 and being used in severely ill patients with COVID-19. Our hypothesis is that perhaps using such drugs before onset of complications will allow better outcomes on this patient population.

Connect with a study center

  • CARDRESEARCH - Cardiologia Assistencial e de Pesquisa

    Belo Horizonte, Minas Gerais 30150240
    Brazil

    Active - Recruiting

  • Pontificia Universidade Catolica de Minas Gerais

    Belo Horizonte, Minas Gerais 30535901
    Brazil

    Site Not Available

  • Fundo Municipal de Saúde de Betim

    Betim, Minas Gerais 32600412
    Brazil

    Active - Recruiting

  • Universidade Federal de Ouro Preto

    Ouro Preto, Minas Gerais 35400000
    Brazil

    Site Not Available

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