Status:
UNKNOWN
Hydroxychloroquine and Lopinavir/ Ritonavir to Improve the Health of People With COVID-19: "The Hope Coalition - 1"
Lead Sponsor:
Cardresearch
Collaborating Sponsors:
Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA
Cytel Inc.
Conditions:
COVID-19
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 dise...
Detailed 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,...
Eligibility Criteria
Inclusion
- Patients with RT-PCR diagnosis of COVID-19 or a clinical condition compatible with COVID-19 and 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 the following 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 Artery Disease, 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 (equivalent to at least 10 mg of oral prednisone per day)
- Willingness to comply with study related procedures
- 3\. Ability to provide informed consent before any protocol-related procedures.
Exclusion
- RT-PCR exam for COVID-19 negative during the screening visit.
- Patients with an acute respiratory condition compatible with COVID-19 being hospitalized;
- Patients with an acute respiratory condition and with moderate to high probability of not being a COVID infection 19;
- Dyspnea secondary to other acute and chronic respiratory causes or infections (eg, decompensated Chronic Obstructive Pulmonary Disease, acute bronchitis, pneumonia, primary pulmonary arterial hypertension);
- Severe respiratory clinical condition, presenting at least ONE of the criteria below:
- Respiratory Rate\> 28 / min;
- Arterial Oxygen Saturation \< 92% with nasal oxygen therapy at 10 l/ min;
- PaO2 / FIO2 \<300 mmHg
- 4\. History of Cardiac Arrhythmia or Long QT Syndrome; 5. Use of Medications that are known to prolong QTc: Citalopram, Venlafaxine, Bupropion and with no possibility of suspension during the period of investigational medical product administration. 6. Inability to take oral medications; 7. Patients on continuous use of Amiodarone and / or PGE5 Inhibitors (Ex .: Sildenafil and similar). 8. Use of Digoxin, Cyclosporine, Cimetidine, Tamoxifen. 9. Use of anticonvulsants, antifungals, immunosuppressants other than corticotherapy. 10. Use of Hydroxychloroquine 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 C classification; 16. Patients with a history of degenerative retinal diseases (patients with retinal 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 severe degenerative neurological diseases and / or severe mental illness; 19. Inability of the patient or representative to give consent or adhere to the procedures proposed in the protocol; 20. Known hypersensitivity and / or intolerance to Hydroxychloroquine. 21. Hypersensitivity and / or intolerance Lopinavir / Ritonavir
- \-
Key Trial Info
Start Date :
June 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
1968 Patients enrolled
Trial Details
Trial ID
NCT04403100
Start Date
June 3 2020
End Date
February 1 2021
Last Update
January 26 2021
Active Locations (4)
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1
CARDRESEARCH - Cardiologia Assistencial e de Pesquisa
Belo Horizonte, Minas Gerais, Brazil, 30150240
2
Pontificia Universidade Catolica de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30535901
3
Fundo Municipal de Saúde de Betim
Betim, Minas Gerais, Brazil, 32600412
4
Universidade Federal de Ouro Preto
Ouro Preto, Minas Gerais, Brazil, 35400000