Covid19NCT04622891
Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection
A study testing Clarithromycin 500mg and Azithromycin in people with Covid19, run by South Valley University at 1 site in Egypt.
Trial summary
The current study was conducted at Qena Governorate, Egypt, during the period from May 2020, to July 2020. The study included 305 COVID-19 cases diagnosed by PCR, patients were randomly assigned to one of three study limps, Azithromycin 500 mg/24 h for 7 days, Clarithromycin 500 /12 h for 7 days, or a control group… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Clarithromycin 500mg and Azithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID-19 cases
- Oxygen saturation > 93%
- Age >18 years
Who cannot join
- Patients <18 years,
- patients with Oxygen saturation < 93%, patients with
- Diabetes mellitus or
- heart failure,
- patients on chemotherapy or immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
south-Vally University faculty of medicine
Qina, Qena Governorate, 868532
About this study
Official title: Efficacy of Clarithromycin in Comparison to Azithromycin in Treatment of Mild COVID-19 Infection, Randomized Controlled Trial
The current study was conducted at Qena Governorate, Egypt, during the period from May 2020, to July 2020. The study included 305 COVID-19 cases diagnosed by PCR, patients were randomly assigned to one of three study limps, Azithromycin 500 mg/24 h for 7 days, Clarithromycin 500 /12 h for 7 days, or a control group with no antibiotics, All three groups received only symptomatic treatment for control of fever and cough
Read the detailed description
The current study was conducted at Qena Governorate, Egypt, during the period from May 2020, to July 2020. The study included 305 COVID-19 cases diagnosed by PCR, patients were randomly assigned to one of three study limps, Azithromycin 500 mg/24 h for 7 days, Clarithromycin 500 /12 h for 7 days, or a control group with no antibiotics, All three groups received only symptomatic treatment for control of fever and cough.
All study participants underwent full clinical evaluation including duration of fever, cough, dyspnea, anosmia or GIT symptoms, C-reactive protein (CRP), serum ferritin, D-dimer, Complete blood count (CBC), non-contrast chest computed tomography (CT) which was repeated 2 weeks after the start of treatment.
The Azithromycin group included, 107 patients, mean age 45.8 ±18 years, 73 male and 34 female, the Clarithromycin group included 99 patients mean age 46.1±19 years, 68 males and 31 female, the control group included 99 patients, with mean age 41.1 ± 18 years, 73 male and 28 female.
- Conditions
- Covid19
- Being tested
- Clarithromycin 500mg, Azithromycin, Placebo
- Keywords
- Azithromycin, clarithromycin, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarithromycin 500mgDrug
Also called active
clarithromycin 500
AzithromycinDrug
Also called active comparison
azithromycin group
PlaceboDrug
Also called control group
control group
| Study group | Role | What they receive |
|---|---|---|
| clarithromycin | Experimental | clarithromycin group Receives: Drug: Clarithromycin 500mg |
| Azithromycin | Active comparator | azithromycin group Receives: Drug: Azithromycin |
| control | Placebo comparator | control group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to fever control
time to complete resolution of fever
Measured: 15 days
Secondary outcomes (1)
PCR conversion
time to PCR conversion from first positive PCR for COVID-19 to negative PCR
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Apr 2020
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- clarithomycin group Azithromycin group control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Rashad, South Valley University
- Investigators
- Alaa Rashad, MD, Principal investigator, associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622891
- Sponsor's protocol ID
- SVU-MED-CHT019-420860
- Status last verified
- Nov 2020
- First submitted
- 6 Nov 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rashad A, Nafady A, Hassan MH, Mansour H, Taya U, Bazeed SES, Aref ZF, Sayed MAA, Nafady-Hego H, Abdelmaksoud AA. Therapeutic efficacy of macrolides in management of patients with mild COVID-19. Sci Rep. 2021 Aug 11;11(1):16361. doi: 10.1038/s41598-021-95900-z.
PubMed 34381155
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Clarithromycin in Comparison to Azithromycin in Treatment of Mild COVID-19 Infection, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04622891
- Acronym / sponsor ID
- SVU-MED-CHT019-420860
- Conditions
- Covid19
- Keywords
- Azithromycin, clarithromycin, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study was conducted at Qena Governorate, Egypt, during the period from May 2020, to July 2020. The study included 305 COVID-19 cases diagnosed by PCR, patients were randomly assigned to one of three study limps, Azithromycin 500 mg/24 h for 7 days, Clarithromycin 500 /12 h for 7 days, or a control group with no antibiotics, All three groups received only symptomatic treatment for control of fever and cough
Detailed description
The current study was conducted at Qena Governorate, Egypt, during the period from May 2020, to July 2020. The study included 305 COVID-19 cases diagnosed by PCR, patients were randomly assigned to one of three study limps, Azithromycin 500 mg/24 h for 7 days, Clarithromycin 500 /12 h for 7 days, or a control group with no antibiotics, All three groups received only symptomatic treatment for control of fever and cough.
All study participants underwent full clinical evaluation including duration of fever, cough, dyspnea, anosmia or GIT symptoms, C-reactive protein (CRP), serum ferritin, D-dimer, Complete blood count (CBC), non-contrast chest computed tomography (CT) which was repeated 2 weeks after the start of treatment.
The Azithromycin group included, 107 patients, mean age 45.8 ±18 years, 73 male and 34 female, the Clarithromycin group included 99 patients mean age 46.1±19 years, 68 males and 31 female, the control group included 99 patients, with mean age 41.1 ± 18 years, 73 male and 28 female.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- clarithomycin group Azithromycin group control group
| Arm | Type | Receives |
|---|---|---|
| clarithromycin | Experimental | Drug: Clarithromycin 500mgclarithromycin group |
| Azithromycin | Active comparator | Drug: Azithromycinazithromycin group |
| control | Placebo comparator | Drug: Placebocontrol group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COVID-19 cases
- Oxygen saturation > 93%
- Age >18 years
Key exclusion criteria (5 listed)
- Patients <18 years,
- patients with Oxygen saturation < 93%, patients with
- Diabetes mellitus or
- heart failure,
- patients on chemotherapy or immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clarithromycin 500mgAlso: activeclarithromycin 500 | Drug | clarithromycin |
| AzithromycinAlso: active comparisonazithromycin group | Drug | Azithromycin |
| PlaceboAlso: control groupcontrol group | Drug | control |
Primary outcome
time to fever control
Time frame: 15 days
time to complete resolution of fever
1 secondary outcome
PCR conversion
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Derived from this study: PubMed 34381155Rashad A, Nafady A, Hassan MH, Mansour H, Taya U, Bazeed SES, Aref ZF, Sayed MAA, Nafady-Hego H, Abdelmaksoud AA. Therapeutic efficacy of macrolides in management of patients with mild COVID-19. Sci Rep. 2021 Aug 11;11(1):16361. doi: 10.1038/s41598-021-95900-z.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa Rashad, MD principal investigator
associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clarithromycin 500mg and Azithromycin in people with Covid19, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to fever control (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04622891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.