CompletedPhase 2

Enoxaparin in COVID-19 Moderate to Severe Hospitalized Patients

Italy301 participantsStarted 2020-05-22

Plain-language summary

General objective of the study To assess the efficacy and safety of enoxaparin in hospitalized patients with moderate to severe COVID-19 (Coronavirus Disease 2019) infection. Study Design The study consists of two parts: * a phase II single-arm interventional prospective study including all patients treated with the study drug; * an observational prospective cohort study including all patients screened for receiving the study drug but not included in the phase II study. Patients will be enrolled from "date of study approval" for 1 month. Each patient will be followed-up for a minimum of 90 days after COVID19 diagnosis.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * For both interventional study and observational cohort, hospitalized patients are eligible to be included if the following criteria apply: Inclusion criteria: * Age \>=18 y * Microbiologically confirmed COVID-19 infection * Patients with moderate to severe disease according to study definitions (see below) * Informed consent to participate and to use data for interventional study, only to use data for observational cohort Exclusion Criteria: * Participants are excluded from the interventional study if any of the following criteria apply: * Thrombocytopenia (platelet count \< 50.000 mm3) * Coagulopathy: INR (International normalized ratio) \>1.5, aPTT ratio \>1.4 * Impaired renal function (clearance to creatinine less than 15 ml/min) * Known hypersensitivity to heparin * History of heparin induced thrombocytopenia * Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignant tumors at hig risk of haemorrhages, recent neurosurgery or ophthalmic surgery, vascular aneurysms, arteriovenous malformations) * Body weight \<45 or \> 150 kg * Concomitant anticoagulant treatment for other indications ( eg atrial fibrillation, venous thromboembolism , prosthetic heart valves). * Dual antiplatelet therapy * Pregnant or breast-feeding women

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mortality

Timeframe: 30 days and 90 days from the first LMWH subcutaneous injection

Effectivness of enoxaparin on the outcome of COVID 19.

Timeframe: This evaluation will be performed at 30 days and 90 days from the first LMWH subcutaneous injection

ICU admission and length of ICU stay

Timeframe: This evaluation will be performed at 14 days (the last day of treatment adminstration), at 30 days and 90 days from the first LMWH subcutaneous injection

Lenght of hospital stay

Timeframe: This evaluation will be performed at 90 days from admission

Trial details

NCT IDNCT04427098

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-29

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