Evidence map›Paper›PMID 39039459›Full record

Trial reportBMC infectious diseases2024

Efficacy and safety of oral ivermectin in the treatment of mild to moderate Covid-19 patients: a multi-centre double-blind randomized controlled clinical trial.

Ananda Wijewickrema, Hasini Banneheke, Arunasalam Pathmeswaran, Fathima Wardha Refai, Malika Kauranaratne, Neelika Malavige, Chandima Jeewandara, Mahendra Ekanayake, Dilhar Samaraweera, Dhanusha Thambavita and 1 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in BMC infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Ananda WijewickremaNational Institute of Infectious Diseases, Angoda, Sri Lanka.
Hasini BannehekeDepartment of Parasitology, Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka. h.banneheke@bangor.ac.uk.
Arunasalam PathmeswaranDepartment of Public Health, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.
Fathima Wardha RefaiDepartment of Parasitology, Medical Research Institute, Colombo, Sri Lanka.
Malika KauranaratneNational Institute of Infectious Diseases, Angoda, Sri Lanka.
Neelika MalavigeDepartment of Immunology and Molecular Medicine, Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Chandima JeewandaraDepartment of Immunology and Molecular Medicine, Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Mahendra EkanayakeBase hospital Homagama and District Hospital, Wethara, Sri Lanka.
Dilhar SamaraweeraColombo South Teaching Hospital, Kalubowila, Sri Lanka.
Dhanusha ThambavitaDepartment of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
Priyadarshani GalappatthyDepartment of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.

Funding

The Medical Research Institute of the Ministry of Health -Sri Lanka Project No:14/2021
6 · The paper itself

Abstract

backgroundEvidence on ivermectin as a treatment for Covid-19 is controversial. A Cochrane review concluded that the efficacy and safety of ivermectin is uncertain (evidence up to April 2022) and WHO recommended its use only in the setting of clinical trials. This study aimed to assess the efficacy and safety of oral ivermectin in hospitalized patients with mild to moderate Covid-19. TRIAL DESIGN AND

methodsA double-blind, randomized placebo-controlled clinical trial was conducted among RT-PCR-confirmed, adults, hospitalised within the first four days of symptoms. Patients received oral ivermectin 24 mg or placebo daily for five days. RT-PCR was repeated on days five and ten. Clinical progression was monitored using the World Health Organization Clinical Progression Scale. Serum ivermectin levels were measured on days three, five, and seven. The primary outcome was the difference in the viral load between day zero and ten in the two groups.

resultsOut of 1699 patients screened, 249 underwent randomization and 127 received ivermectin, and 122 placebo. D10 median viral load for E gene (IQR) was 2,000 copies/mL (100 - 20,500) with ivermectin (n = 80) and 4,100 copies/mL (1,000-65,600) with placebo (n = 81, p = 0.028), per protocol analysis. The difference in Log viral load between day zero and ten between ivermectin and placebo was 3.72 and 2.97 respectively (p = 0.022). There was no significant difference in the WHO clinical progression scale or the adverse effects. Ivermectin blood levels taken before or with meals were not significantly different. Only 7 and 17 patients achieved blood levels above 160ng/ML and 100ng/ML respectively and they did not achieve a significantly lower viral load.

conclusionAlthough ivermectin resulted in statistically significant lower viral load in patients with mild to moderate Covid-19, it had no significant effect on clinical symptoms. TRIAL REGISTRATION NUMBER: SLCTR/2021/020, Sri Lanka Clinical Trials Registry. 19/07/2021.

Indexed as

COVID-19 Drug TreatmentIvermectinSARS-CoV-2Viral LoadAdministration, OralAdultAgedAntiviral AgentsCOVID-19Double-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeAntiviral AgentsIvermectinDouble-blindIvermectinRandomized placebo-controlled clinical trialRT-PCR-confirmed Covid-19 infectionSerum ivermectin levelsViral loadWorld Health Organization Clinical Progression Scale

Identifiers

PMID39039459
PMCPMC11264372

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.