Effectiveness of the combined treatment with hydroxycloroquine and azithromycin vs lopinavir/ritonavir + hydroxycloroquine in hospitalized patients with confirmed COVID-19 infection

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001605-23-ES

Enrollment

108

Registered

2020-05-31

Start date

2020-05-29

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19 infection

Interventions

Trade Name: Lopinavir/Ritonavir Accord Pharmaceutical Form: Tablet INN or Proposed INN: LOPINAVIR CAS Number: 192725-17-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration nu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - RT-PCR confirmed. - 18-80 years. - Pneumonia confirmed by Rx chest: pneumonia CURB92% 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 68

Exclusion criteria

Exclusion criteria: ->7 days from the onset of symptoms - Severe disease Covid 19, defined by any of the following: FR500ms and risk-benefit is valued between a460-500 ms. Does not start treatment if ECG shows changes in channel-patties and risk-benefit is valued if there are other abnormalities. - Patients with glucose 6 phosphate dehydrogenase deficiency.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Respiratory severity scale Brescia-COVID;Timepoint(s) of evaluation of this end point: During hospital admission;Main Objective: To compare the proportion of patients with COVID-19 infection who achieve a score of less than 2 on the Brescia-COVID respiratory severity scale after treatment with hidroxycloroquine + azithromycin versus actual practice;Secondary Objective: - Time to reach a score lower than 2 on the Brescia-COVID respiratory severity scale. - Proportion of subjects who die and time to death. - Subject ratio (negative PCR) at the end of the treatment and time until denial. - Proportion of subjects admitted to the ICU, time until admission to the ICU and length os stay. - Duration of the hospital discharge. - Time until intubation or invasive mechanical ventilation. - Duration of the invasive mechanical ventilation. - Proportion of subjects with adverse effects associated with the received treatment.	—

Measure

Time frame

Primary end point(s): Respiratory severity scale Brescia-COVID;Timepoint(s) of evaluation of this end point: During hospital admission;Main Objective: To compare the proportion of patients with COVID-19 infection who achieve a score of less than 2 on the Brescia-COVID respiratory severity scale after treatment with hidroxycloroquine + azithromycin versus actual practice;Secondary Objective: - Time to reach a score lower than 2 on the Brescia-COVID respiratory severity scale. - Proportion of subjects who die and time to death. - Subject ratio (negative PCR) at the end of the treatment and time until denial. - Proportion of subjects admitted to the ICU, time until admission to the ICU and length os stay. - Duration of the hospital discharge. - Time until intubation or invasive mechanical ventilation. - Duration of the invasive mechanical ventilation. - Proportion of subjects with adverse effects associated with the received treatment.

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Secondary

Measure	Time frame
Secondary end point(s): - Mortality from any cause and time until the death - Days when punctuation in Brescia scale <2 - Length of hospital stay - Time until intubation or invasive ventilation - Invasive ventilation duration time - Adverse effects - ct-PCR SARS-Cov-2: 7, 14 and 21 days from start of treatment - Time until admission to ICU and duration of stay in ICU - Hospital discharge and time to hospital discharge - Age - Sex - Comorbidity;Timepoint(s) of evaluation of this end point: During hospital admission	—

Measure

Time frame

Secondary end point(s): - Mortality from any cause and time until the death - Days when punctuation in Brescia scale <2 - Length of hospital stay - Time until intubation or invasive ventilation - Invasive ventilation duration time - Adverse effects - ct-PCR SARS-Cov-2: 7, 14 and 21 days from start of treatment - Time until admission to ICU and duration of stay in ICU - Hospital discharge and time to hospital discharge - Age - Sex - Comorbidity;Timepoint(s) of evaluation of this end point: During hospital admission

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Countries

Spain

Contacts

Public ContactInés Pérez Francisco

Investigation Institute Bioaraba

INES.PEREZFRANCISCO@osakidetza.eus

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026