Chloroquine as Antiviral Treatment in Coronavirus Infection 2020

Multicenter, Randomized, Open-label, Non-commercial, Investigator-initiated Study to Evaluate the Efficacy and Safety of Chloroquine Phosphate in Combination With Telemedicine Care in the Risk Reduction of COVID-19 Related Hospitalization or Death, in Ambulatory Patients With COVID-19 Being at Risk of Serious Complications

The aim of the study is to evaluate whether the therapy with chloroquine phosphate (CQ, in combination with telemedical approach) in addition to standard care is effective and safe in reducing composite endpoint of COVID-19-related hospitalization or all cause death, in ambulatory patients with SARS-SoV-2 infection at particular risk of serious complications due to advanced age and/or comorbid conditions (in comparison with subjects not treated with CQ but receiving standard care and supervised telemedically).

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Chloroquine phosphate; Other: Telemedicine

Detailed Description

Until now there are no evidence-based, good-quality data from sufficiently powered clinical trials supporting the use of any antiviral medicines or immunomodulatory therapies in the management or prophylaxis of COVID-19; however there are currently being initiated studies in Europe and U.S., and a few registered studies are ongoing in China. Currently two groups of medicines are hypothesized to be effective therapeutic options in COVID-19: (1) classical antiviral drugs interfering with pathogen dissemination / replication, and (2) compounds inhibiting host inflammatory reactions, especially (and potentially selectively) in respiratory tract / system (cytokine inhibitors and specific antibodies). Special hopes are placed in quinoline derivatives such as chloroquine (CQ), based on some unpublished data from China and a few experiments in vitro. CQ is an old antimalarial drug that has been used for more than 50 years in the therapy and prevention of this parasitosis. Anti-inflammatory features of quinolone derivatives such as CQ or hydroxychloroquine have also been used in rheumatology (for the therapy of lupus erythematosus or rheumatoid arthritis) due to the inhibition of the production of proinflammatory cytokines. The effectiveness (and safety) of CQ in COVID-19 has not been investigated in sufficiently powered RCTs until now.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Ul. Borowska 213
    • Wrocław, Ul. Borowska 213, Poland, 50-556
      • Uniwersytecki Szpital Kliniczny
  • Ul. Szwajcarska 3
    • Poznań, Ul. Szwajcarska 3, Poland, 61-285
      • Wielospecjalistyczny Szpital Miejski

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA

1. age >=60 years OR age 18-59 years with one of the following conditions:

   1. chronic lung disease
   2. chronic cardiovascular disease
   3. diabetes
   4. malignancy diagnosed within 5 years prior to enrollment
   5. history of chronic kidney disease
   6. atrial fibrillation
   7. past haemorrhagic stroke, ischemic stroke or transient CNS ischemia
   8. obesity defined as BMI ≥ 30 kg / m2
   9. 10-year risk of fatal cardiovascular disease
2. SARS-CoV-2 infection confirmed in RT-PCR (nasopharyngeal swab)
3. Hospitalization not required based on clinical judgement
4. Ability to participate in telemedical care

EXCLUSION CRITERIA

1. Lack of written informed consent
2. Possible failure to comply with the protocol
3. Chloroquine, hydroxychloroquine therapy within 30 days prior to enrollment
4. Antiviral therapy within 14 days prior to enrollment
5. Contraindications to chloroquine (pregnancy, breast-feeding, severe renal insufficiency, amiodarone therapy, alcohol disease, haematological disorders, epilepsia, porphyria, liver disease/cirrhosis, retinopathy, fainting/syncope, myasthenia)
6. Hypersensitivity to chloroquine or drug excipients
7. HIV infection
8. Other relevant circumstances/conditions based on clinical judgement
9. Concurrent participation in another interventional clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHLOROQUINE; Standard of care + chloroquine phosphate + telemedical approach.	Drug: Chloroquine phosphate; Oral chloroquine phosphate for 14 days; Other: Telemedicine; Telemedical supervision for 42 days
Other: CONTROL GROUP; Standard of care + telemedical approach.	Other: Telemedicine; Telemedical supervision for 42 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19-related hospitalization or all-cause death	Composite endpoint of COVID-19-related hospitalization or all-cause death	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in COVID-19 symptoms	Decrease in self-reported symptoms of novel coronavirus infection. Non-dichotomous symptoms (e.g. syncope is dichotomous - yes or no) such as dyspnoea will be self-evaluated by patients using the 0-3 scale with the severity increasing with the punctation (0-no symptoms, 1-mild symptoms, 2-moderate symptoms, 3-severe symptoms).	15 days and 42 days
Development of pneumonia	Based on X-ray, microbiology and laboratory results	42 days
Development of coronavirus infection-related complications	Acute respiratory distress syndrome, bacterial infection, shock, sepsis, etc	42 days

Collaborators and Investigators

• Sponsor: Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Actual): December 17, 2020
• Study Completion (Actual): December 17, 2020

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Amebicides; Filaricides; Antinematodal Agents; Anthelmintics; Chloroquine; Chloroquine diphosphate
• Other Study ID Numbers: WROCLAW CORONA STUDY 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No