Coronavirus Covid 19 infection MedDRA version: 20.1 Level: HLT Classification code 10047468 Term: Viral lower respiratory tract infections System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Kaletra
Product Name: Kaletra
Product Code: [-]
Pharmaceutical Form: Tablet
INN or Proposed INN: LOPINAVIR
Current Sponsor code: -
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures; 2. Agrees to the collection of nasopharyngeal swabs and venous blood samples per protocol 3. Male or female adult >=18 years of age at time of enrolment; 4. Has laboratory-confirmed SARS-CoV-2 infection as determined by an approved molecular test (PCR) in Italy; 5. Being symptomatic for less than 5 days before starting therapy; 6. Do not meet criteria for immediate hospitalization (NEWS = 2). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 261 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 174
Exclusion criteria
Exclusion criteria: A. Requires immediate hospitalization or mechanical ventilation and/or supplemental oxygen therapy or have a NEWS = 2; B. Having already receive any of the trial drug less than 1 month before randomization C. Being concurrently involved in another trial for COVID-19 D. Pregnancy (based on home test) E. HIV infection (based on the anamnesis) F. Use of any antiretroviral medication G. Hypersensitivity to any of the used in the experimental compound including excipients H. Use of medications that are contraindicated with chloroquine (Full list will be reported in the standard operative protocol to be developed in each of the five recruiting Centre). I. Having a pacemaker and / or history or current evidence of clinically significant cardiac arrhythmia J. Active or clinically significant cardiac disease including congestive heart failure (New York Heart Association Class III or higher) K. Severe liver injury (Child-Pugh Class B or C); L. Use of concomitant medications that prolong the QT/QTc interval (Full list will be reported in the standard operative protocol to be developed in each of the five recruiting Centre) [42] M. Receiving drug that cannot be co-administered with any of the experimental compound (Full list will be reported in the standard operative protocol to be developed in each of the five recruiting Centre) N. Autoimmune diseases receiving therapy at the time of randomization. O. Women of childbearing potential and fertile men must agree to use at least one primary form of contraception for the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the effectiveness of therapy in reducing the proportion of subjects with who still have viruses in the upper airways after 7 days of therapy Evaluation of the effectiveness of therapy in reducing the proportion of hospitalized subjects within 14 days of starting therapy.;Secondary Objective: Evaluation of the effectiveness of therapy in reducing the proportion of subjects with who still have viruses in the upper airways after 14 and 28 days of therapy. Evaluation of the effectiveness of therapy in reducing the proportion of hospitalized subjects within 7 or 28 days of starting therapy. 7, 14 and 28 day drug safety and tolerability profile Modeling of blood and biochemical parameters between T0 and T28;Primary end point(s): Virologic outcome. Proportion of participants with undetectable SARS-CoV-2 gene E and gene M at day 7 after randomization. Clinical outcome. Proportion of participants who need not hospitalization (NEWS = 2) by day 14 after randomization.;Timepoint(s) of evaluation of this end point: 7 days 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of participants with undetectable SARS-CoV-2 gene E and gene M at day 14 after randomization, by arm. Proportion of participants with undetectable SARS-CoV-2 gene E and gene M at day 28 after randomization, by arm. Proportion of participants who need not hospitalization (NEWS = 2) by day 7 and 28 after randomization, by arm. Proportion of patients in each category at point N at time 0, 7, 14 and 28, by arm Mean value of category at point N by arm at time 0,7,14 and 28 Proportion of participants with any adverse event (grade = 2 according to CTCAE) at day 7, 14 and 28, by arm. Proportion of participants with severe adverse events (grade = 3 according to CTCAE) at day 7, 14 and 28, by arm. Mean variation of value of biomarker parameters reported in end point section (point I to M) from base line to day 7, 14 and 28 after randomization, by arm.;Timepoint(s) of evaluation of this end point: To see the study protocol | — |
Countries
Italy
Contacts
Public ContactDipartimento di Epidemiologia Digno
Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
Outcome results
None listed