E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Coronavirus disease 2019 (COVID-19) |
|
E.1.1.1 | Medical condition in easily understood language |
Coronavirus disease 2019 (COVID-19) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051905 |
E.1.2 | Term | Coronavirus infection |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to
clinical status assessed by a 7-point ordinal scale on Day 14 |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of RDV |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Willing and able to provide written informed consent, or with a legal
representative who can provide informed consent, or enrolled under ICH
E6(R2) 4.8.15 emergency use provisions as deemed necessary by the
investigator (participants ≥ 18 years of age), or willing and able to
provide assent (participants ≥ 12 and < 18 years of age, where locally
and nationally approved) prior to performing study procedures. For
participants ≥ 12 and < 18 years of age, a parent or legal guardian
willing and able to provide written informed consent prior to performing
study procedures
2) Aged ≥ 18 years (at all sites), or aged ≥ 12 and < 18 years of age
weighing ≥ 40 kg (where permitted according to local law and approved
nationally and by the relevant institutional review board [IRB] or
independent ethics committee [IEC])
3) SARS-CoV-2 infection confirmed by PCR ≤ 4 days before
randomization
4) Currently hospitalized
5) SpO2 > 94% on room air or requiring supplemental oxygen at
screening
6) Radiographc evidence of pulmonary infiltrates
7) Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Protocol Appendix 3. |
|
E.4 | Principal exclusion criteria |
1) Participation in any other clinical trial of an experimental treatment for COVID-19
2) Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing
3) Evidence of multiorgan failure
4) Mechanically ventilated (including V-V ECMO) ≥ 5 days, or any
duration of V-A ECMO.
5) ALT or AST > 5 x upper limit of normal (ULN)
6) Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula
for participants ≥ 18 years of age {Cockcroft 1976} and Schwartz
Formula for participants < 18 years of age
7) Positive pregnancy test (Protocol; Appendix 3)
8) Breastfeeding woman
9) Known hypersensitivity to the study drug, the metabolites, or formulation excipient |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Clinical status assessed by a 7-point ordinal scale on Day 14 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
The proportion of participants with treatment emergent adverse events |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From initiation of study medication until Day 14 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Two part open-label study; each part consists of two treatment groups |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 44 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
China |
France |
Germany |
Hong Kong |
Italy |
Japan |
Korea, Republic of |
Netherlands |
Singapore |
Spain |
Sweden |
Switzerland |
Taiwan |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 4 |